ANTIPANDEMIC TECHNOLOGY
C O V I D 1 9
Medical Supplies
DPI COVID TEST
ANTIPANDEMIC TECHNOLOGY
VENTILATORS
Dispositivi
di protezione individuale
• MASK CHIRURGICHE N95/FFP2/FFP3/KN95
Dispositivi
di protezione individuale
• MASK
• TUTE DI PROTEZIONE
• CAMICI CHIRURGICI
• GUANTI
N95/N99/FFP2
N95/N99/FFP2
Note:
CERTIFICATION OF REGISTRATION
Page 1 of 6
Certificate – Cертификат – 證明書 – Certificat – 증명서 – ةداهش
Report No. TPGD20032623435
TECHNICAL CONSTRUCTION FILE | ||||||
Report Reference No....................... : | TPGD20032623435 | |||||
Tested by (+ signature) .................... : | Xxxxxxx Xxxx | ..................................................... | ||||
Approved by (+ signature) ............... : | Xxxxx Xxx | ..................................................... | ||||
Date of issue.................................... : | Mar. 26, 2020 | |||||
Testing Laboratory ........................ : | Shanghai Global Testing Services Co., Ltd. | |||||
Address............................................ : | Floor 2nd, Building D-0, Xx. 000, Xxxxxx Xxxx, Xxxxxxx Xxxxxxxx, Xxxxxxxx, Xxxxx. | |||||
Testing procedure ...................... : | TL [×] | TMP[ | ] | WMT[ ] | ||
Applicant’s name ........................... : | Dongguan xxxx protective equipment co. LTD | |||||
Address............................................ : | Room 201, building 2, Xx. 0, xxxxxxx xxxxxxxxx xxxx, xxxxx xxxx, xxxxxxxx xxxx, xxxxxxxxx xxxxxxxx,xxxxx | |||||
Test specification: | ||||||
Standard........................................... : | EN 149:2001+A1:2009 | |||||
Type of Test ................................... : | PST[ | ] | Registration（type test） [×] | |||
Non-standard test method…………..: | N/A | |||||
Manufacturer.................................... : | Dongguan xxxx protective equipment co. LTD | |||||
Adress.............................................. : | Room 201, building 2, Xx. 0, xxxxxxx xxxxxxxxx xxxx, xxxxx xxxx, xxxxxxxx xxxx, xxxxxxxxx xxxxxxxx,xxxxx | |||||
Product name................................... : | Daily protective masks | |||||
Model No. ....................................... : | KN95 | |||||
This file is Not being issued by FDA. We, GTS, as the 3rd party, produce it, intended to facilitate customer display & transmit information. The following contents, FDA registered Facility/Owner/Operator&FDA listing Medical Device, are excerpted from database at xxx.xxx.xxx.
Establishment:
Dongguan xxxx protective equipment co. LTD
Room 201, building 2, Xx. 0, xxxxxxx xxxxxxxxx xxxx, xxxxx xxxx, xxxxxxxx, xxxxxxxxx,Xxxxx 523000
Registration Number / FEI Number*:
Type Approved
* Firm Establishment Identifier (FEI) should be used for identification of entities within the imports message set
Status: Active
Date of Registration Status: 2020
Owner/Operator
Dongguan xxxx protective equipment co. LTD
Room 201, building 2, Xx. 0, xxxxxxx xxxxxxxxx xxxx, xxxxx xxxx, xxxxxxxx, xxxxxxxxx,Xxxxx 523000
Owner/Operator Number: 10066222
Official Correspondent
Contact Name: Xxxxx Xxxxx Xx Manager
Room 201, building 2, Xx. 0, xxxxxxx xxxxxxxxx xxxx, xxxxx xxxx, xxxxxxxx, xxxxxxxxx,Xxxxx 523000
Tel: x00- 000-00000000 E-mail: xxxxx000@000.xxx
Devices Listing Information
Proprietary Name | Product Codes | Device Class | Listing Number | Establishment Operations |
Daily Protective Mask | LYU | 1 | D38**** | Manufacturer |
Disposable Face Mask | LYU | 1 | D38**** | Manufacturer |
Please careful protect your Listing Number.
Signature:
Need help? Contact us, GTS, at x00(000) 00000000 & xxxx@xxx-xxx.xxx FDA CERTIFICATE NUM: GTS23545
This documentis issuedsubjectto GTS CENERALCONDITIONSOF SERVICE, and shall notbe reproducedexceptin full or withwrittenapprovalby GTS Testing.
Shanghai Global Testing Services Co., Ltd.
Floor 2nd, Building D-0, Xx. 000, Xxxxxx Xxxx, Xxxxxxx Xxxxxxxx, Xxxxxxxx, Xxxxx.
Tel: (00-00) 0000 0000 Fax: (00-00) 0000 0000 E-mail: xxxx@xxx-xxx.xxx Web Site: xxxx://xxx.xxx-xxx.xxx
Form QAT_10-M04, version 00, effective since March 6th, 2020
Certificate of Compliance
No. 0P200330E.DIP00079
Technical Construction File no. TPGD20032623435
Certificate’s
Holder:
Dongguan Xxxx Protective Equipment Co. Ltd
Room 201, Building 0, Xx. 0, Xxxxxxx Xxxxxxxxx Xxxx, Xxxxx Xxxx, Xxxxxxxx Xxxx, Xxxxxxxxx Xxxxxxxx, Xxxxx
Certification ECM Mark:
European Conformity
Product: Model(s):
Verification to:
Daily protective masks (Not Sterile) 99_95A
Standard:
EN 149: 2001+A1:2009
related to CE Directive(s):
R 2016/425 (Personal Protective Equipment)
Remark: This document has been issued on a voluntary basis and upon request of the manufacturer. It is our opinion that the technical documentation received from the manufacturer is satisfactory for the requirements of the ECM Certification Mark. The conformity mark above can be affixed on the products accordingly to the ECM regulation about its release and its use.
Additional information and clarification about the Marking:
The manufacturer is responsible for the CE Marking process, and if necessary, must refer to a Notified Body. This document has been issued on the basis of the regulation on ECM Voluntary Mark for the certification of products. RG01_ECM rev.3 available at: xxx.xxxxxxxxx.xx
Issuance date: 30 March 2020
Expiry date: 29 March 2025
Reviewer Approver
Technical expert ECM Service Director
Xxxxxx Xxxxx Xxxx Xxxxxxx
Ente Certificazione Macchine Srl
Via Ca’ Bella, 243 – Loc. Castello xx Xxxxxxxxxx – 40053 Valsamoggia (BO) - ITALY
x00 000 0000000 x00 000 0000000 xxxx@xxxxxxxxx.xx ß xxx.xxxxxxxxx.xx
N95/FFP2 RIF B03
FFP3
FFP3
C O V I D 1 9
Ventilators
Ventilatori
• CRIUSV6
• Disponibile in stock
Ventilatori
• CRIUSV6
This invasive ICU Ventilator by Northern features fully electric controls & ventilation modes includes spn-CPAP, PC-CMV, PC-ACV, PC-SIMV, PC Dual PAP, PC-AMV, PC-APRV, PC-MMVI VC-CMV, VC-ACV & VC- SIMV.
Features;
• Fully Electric Controls
• Blower Drive Ventilatio Type
• Suaable far Adult, Pediatrie & Neonate patient ypes
• Adjustable far pa ient height
Ve n t i lat i on Modes;
• Spn-CPAR PC-CMV, PC-ACV, PC-SIMV, PC-Dual PAP, PC-AMV, PC APRV, PC-MMV, VC-CMV, VC- ACV & VC-SIMV
• Manual breatt1, 02 Therapy, Screen lock inspiratory
hold, expiratory hold, sigh, ATC, PCVRJ PPS, Calibrate, Nebulizer & 02 Suction
• CRIUSV6
• Real time waveforms: Paw, Flow, Volume, ETCO2, SPO2
• OptianaL CO2 & SPO2 (related parameters)
• Loops: P-V: V-F1ow, F1ow-P
• Trends: 1s, 5s, 1 min, 1Omini 30m1n & 60min
• Tidal Volume: 1O -2000ml
• PEEP/CPAP O - 30cmH20
• Oxygen: 21 - 100%
• 'l:E Ratio: 1:1O to 4:1
• :In spi ratory Time (T1): 0.2 - 5 secs
• Flow Trigger: 0.2 to 15I/mìn
• Pressure Trigger: -0.5 - -20cmH2O
• Pressure Control: 5 to 90cmH20, added to PEEP/CPAP
• Pressure Support O to 90crnH20, added to PEEP/CPAP
• Pressure Ramp: O to 2s
• VG70
• Disponibile in stock
Ventilatori
Technical Specification
Ventilation Modes
• VG70
VCV(A/C) PCV(A/C) PRVC SIMV(VCV)+PSV SIMV(PCV)+PSV SIMV(PRVC)+PSV SPONT/ CPAP+PSV
BIVENT+PSV NIV/CPAP NIV-T NIV-S/T
Parameters
• Tidal Volume: 20~2000 ml
• Respiration Rate: 1~80 bpm
• Tinsp: 0.2~9 s
• Tslope: 0~2 s
• Tpause: 0~4 s
• I:E Ratio: 1:10~4:1
• FiO2: 21%~100%
• Trigger Sensitivity: Pressure (-20~0 cmH2O, above PEEP)
Flow (0.5~20 LPM)
• PEEP: 0~35 cmH2O
• Psupport: 0~70 cmH2O
• Pinsp: 5~70 cmH2Oì
Special Procedures
Apnea Ventilation Smart Suction Manual Breath Insp/ Exp Hold ETCO2 Measurement Nebulization Waveform Freeze
Monitoring
• Pressure Value: Ppeak, Pplat, Pmean, Pmin, PEEP
• Volume / Flow Value: Vti, Vte, MV, MVspont
• Time Value: ftotal,fspont, I:E
• Real Time Curves: Pressure-Time, Flow-Time,
Volume-Time waveforms
Pressure-Volume, Volume-Flow, Flow-Pressure loops
• Gas Monitoring: FiO2, ETCO2
• Calculated Values: Compliance(C) Resistance(R)
MVleak RSBI WOB PEEPi
Alarm
Paw high / low MVe high / low Circuit disconnnect FiO2 high / low Inspiration / Expiratory tidal volume low
High Respiration Rate Apnea AC Failure Nebulizer On
Low Battery Air /O2 supply down High / Low PEEP Leakage out of range Occlusion
Technical Data
• Screen: 12〞TFT color touch screen (detachable)
• Supply Gas: O2, 0.28~0.6 MPa
• Power Supply: AC100~240 V, 50 Hz/60 Hz
• Communication Interface: RS-232 Port, Nurse call Port, Ethernet Port
• Dimension (WxDxH): 322 mm x 375 mm x 366 mm (Main Unit)
547 mm x 675 mm x 950 mm (Cart)
• Weight: 12.5 kg (Main Unit) 25 kg (Cart)
Ventilatori
• VG70
Superior Mobile ICU ventilator
• Comprehensive ICU ventilator including BIVENT and PRVC
• Compact, big capacity battery, no air compressor, intra-hospital mobility
• Flexible device configuration: equipped on a trolley, bed or
ceiling pendant
Cost Effective Solution
• Unique metal-based, autoclavable, heated exhalation valve
• Built-in flow sensor, non-consumable design
• Upgradeable ventilation system software, with an available USB port
360° Visible Alarm Lamp
12”TFT Detachable Touch Screen
Ultra Quiet Turbine Inside
Integrated Power Supply Solution
Built-in Battery, With Extended Backup Option
Ventilatori
Auto-detect and Adjust Leak Compensation
Automatically Adapt to Patient ’s Breathing Pattern
Multi-parameter Monitoring
• VG70
An Optimal Combination of Invasive and Noninvasive Ventilator
•
•
As noninvasive ventilation is used increasingly in a wide range of clinical situations, we offer a dual solution
VG70 combines the advantages of a flexible noninvasive ventilator with a full-featured invasive ventilator for the ICU
Safe Ventilation Through Whole Treatment Phase
Initial Treatment Phase
• Noninvasive ventilation mode associated with decreased intubation rates, shortened patient stays, improved patient comfort, and a reduced risk of cross infection
• Preset patient’s height and IBW. Reduce clinician’s workload
Stable Condition Phase
• PRVC and BIVENT employ lung-protective strategies, delivering intelligent ventilation
• Comprehensive lung mechanics monitoring include compliance, airway resistance, PEEPi and time constant
• Three waveforms & three loops with user-friendly display provide a continuous monitoring of the patient’s condition
Weaning Phase
• Various ventilation modes enhance the weaning process
• The unique trigger and leakage compensation system safeguards each and every patient breath resulting in smooth and comfortable breathing, avoiding extra workload on the patient and promoting recovery
• RSBI and WOB provide accurate reference for weaning
Rehab Phase
• Data export port provides connection to hospital monitors and Patient Data Management Systems
• Provides pressure support for the patient when spontaneous breathing is present
March 20, 2020
Xxxxx Xxxxx-Xxxxx, Group RA QA Director Primerdesign Ltd.
Xxxx 0, Xxxxxxxxx Xxxxx, Xxxxxxxxx Xxxx, Xxxxxxxxx, XX00 0XX, XX
Device: Primerdesign Ltd COVID-19 genesig Real-Time PCR assay.
Company: Primerdesign Ltd.
Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal swab specimens from patients suspected of COVID- 19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories.
Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
Dear Xx. Xxxxx-Xxxxx:
This letter is in response to your1 request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of your product,2 pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).
On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19.3 Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of HHS then declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 subject to the terms of any authorization issued under Section 564(a) of the Act.4
1 For ease of reference, this letter will use the term “you” and related terms to refer to the Primerdesign Ltd.
2 For ease of reference, this letter will use the term “your product” to refer to the Primerdesign Ltd COVID-19 genesig Real-Time PCR assay used for the indication identified above.
3 On February 11, 2020, the virus tentatively named 2019-nCoV was formally designated as Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Also on February 11, 2020, the disease caused by SARS-CoV-2 was formally designated as Coronavirus Disease 2019 (COVID-19). This document uses the updated names.
4 U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3. February 4, 2020.
Page 2 – Xxxxx Xxxxx-Xxxxx, Primerdesign Ltd
Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of your product, described in the scope Section of this letter (Section II), subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of your product meets the criteria for issuance of an authorization under Section 564(c) of the Act, because I have concluded that:
1. The SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product; and
3. There is no adequate, approved, and available alternative to the emergency use of your product.5
II. Scope of Authorization
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited to the indication above.
Authorized Product Details
Your product is for the qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal swab specimens from patients suspected of COVID-19 by their healthcare provider. The SARS- CoV-2 is generally detectable in oropharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.
To use your product, SARS-CoV-2 nucleic acid is first extracted, isolated and purified from oropharyngeal swabs. The purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and detection with an authorized RT-PCR Master Mix on authorized Real- Time PCR instrument(s). The Primerdesign Ltd COVID-19 genesig Real-Time PCR assay includes the following materials or other authorized materials: oasig OneStep 2X RT-qPCR Master Mix, COVID-19 Primers & Probe Mix, Oasig resuspension buffer, Template preparation buffer, Water RNase/DNase free, Genesig COVID-19 Positive control template and Genesig Easy RNA Internal extraction control (IEC).
Your product requires the following control materials, or other authorized control materials, that
5 No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.
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are processed in the same way as the patient samples and are to be run as outlined in the Instructions for Use for your product:
• Genesig Easy RNA Internal extraction control (IEC) - added prior to nucleic acid extraction to measure RNA extraction purity, detect PCR inhibition and confirm the integrity of the PCR run.
• Genesig COVID-19 Positive control template - contains synthetic DNA representing the SARS-CoV-2 genomic region of interest. The positive control is used to monitor for failures of primer/probe reagents and reaction conditions.
• Negative Extraction Control (NEC) – RNase/DNase free water, run each time RNA is extracted from a clinical specimen or sample.
• No Template (Negative) Control - DNase/RNase free water used to monitor non- specific amplification, cross-contamination during experimental setup, and nucleic acid contamination of reagents.
Your product also requires the use of additional authorized materials and authorized ancillary reagents that are not included with your product and are described in the Instructions for Use.
The above described product, when labeled consistently with the labeling authorized by FDA, entitled “Primerdesign Ltd COVID-19 genesig Real-Time PCR assay Instructions for Use” (available at xxxxx://xxx.xxx.xxx/xxxxxxx-xxxxxxx/xxxxxxxxx-xxxxxxxxxx-xxxxxxx- devices/emergency-use-authorizations), which may be revised in consultation with, and with concurrence of, the Division of Microbiology Devices (DMD)/Office of Health Technology 7 Office of In Vitro Diagnostics and Radiological Health (OHT7-OIR)/Office of Product Evaluation and Quality (OPEQ)/Center for Devices and Radiological Health (CDRH), is authorized to be distributed to and used by authorized laboratories under this EUA, despite the fact that it does not meet certain requirements otherwise required by applicable federal law.
Your product is authorized to be accompanied by the following product-specific information pertaining to the emergency use, which is required to be made available to healthcare providers and patients:
• Fact Sheet for Healthcare Providers: Primerdesign Ltd COVID-19 genesig Real- Time PCR assay
• Fact Sheet for Patients: Primerdesign Ltd COVID-19 genesig Real-Time PCR
assay
I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of your authorized product, when used for the qualitative detection of SARS-CoV-2 and used consistently with the Scope of Authorization of this letter (Section II), outweigh the known and potential risks of your product.
I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that your product may be effective for the indication above, when used consistently with the Scope of Authorization of this letter (Section II), pursuant to Section 564(c)(2)(A) of the Act.
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FDA has reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section I above, and concludes that your product (as described in the Scope of Authorization of this letter (Section II)) meets the criteria set forth in Section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of your product under this EUA must be consistent with, and may not exceed, the terms of this letter, including the Scope of Authorization (Section II) and the Conditions of Authorization (Section IV). Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS's determination under Section 564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under Section 564(b)(1), your product is authorized for the indication above.
This EUA will cease to be effective when the HHS declaration that circumstances exist to justify the EUA is terminated under Section 564(b)(2) of the Act or when the EUA is revoked under Section 564(g) of the Act.
III. Waiver of Certain Requirements
I am waiving the following requirements for your product during the duration of this EUA:
• Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of your product.
IV. Conditions of Authorization
Pursuant to Section 564(e) of the Act, I am establishing the following conditions on this authorization:
Primerdesign Ltd (You) and Authorized Distributor(s)6
A. Your product must comply with the following labeling requirements under FDA regulations: the intended use statement (21 CFR 809.10(a)(2), (b)(2)); adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5), (7), and (8)); any appropriate limitations on the use of the device including information required under 21 CFR 809.10(a)(4); and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).
B. You and authorized distributor(s) will make your product available with the authorized labeling to authorized laboratories. You may request changes to the authorized labeling. Such requests will be made in consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.
6 “Authorized Distributor(s)” are identified by you, Primerdesign Ltd, in your EUA submission as an entity allowed to distribute your device.
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C. You and authorized distributor(s) will provide to authorized laboratories the Fact Sheet for Healthcare Providers and the authorized Fact Sheet for Patients. You may request changes to the authorized Fact Sheets. Such requests will be made in consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.
D. You and authorized distributor(s) will make available on your website(s) the Fact Sheet for Healthcare Providers and the Fact Sheet for Patients.
E. You and authorized distributor(s) will inform authorized laboratories and relevant public health authorities of this EUA, including the terms and conditions herein, and any updates made to your product, authorized labeling and authorized Fact Sheets.
F. Through a process of inventory control, you and authorized distributor(s) will maintain records of the authorized laboratories to which they distribute the test and number of tests they distribute.
G. You and authorized distributor(s) will collect information on the performance of your product. You will report to FDA any suspected occurrence of false positive and false negative results and significant deviations from the established performance characteristics of the product of which you become aware.
H. You and authorized distributor(s) are authorized to make available additional information relating to the emergency use of your product that is consistent with, and does not exceed, the terms of this letter of authorization.
Primerdesign Ltd (You)
I. You will notify FDA of any authorized distributor(s) of your product, including the name, address, and phone number of any authorized distributor(s).
J. You will provide its authorized distributor(s) with a copy of this EUA and communicate to authorized distributor(s) any subsequent amendments that might be made to this EUA and its authorized accompanying materials (e.g., Fact Sheets).
K. You may request changes to the Scope of Authorization (Section II in this letter) of your product. Such requests will be made in consultation with DMD/OHT7- OIR/OPEQ/CDRH, and require concurrence of, Office of Counterterrorism and Emerging Threats (OCET)/Office of the Chief Scientist (OCS)/Office of the Commissioner (OC) and DMD/OHT7-OIR/OPEQ/CDRH.
L. You may request the addition of other instruments and associated software for use with your product. Such requests will be made in consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.
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M. You may request the addition of other extraction methods for use with your product. Such requests will be made in consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.
N. You may request the addition of other specimen types for use with your product. Such requests will be made in consultation with, and require concurrence of, DMD/OHT7- OIR/OPEQ/CDRH.
O. You may request the addition and/or substitution of primers or probes for use with your product. Such requests will be made in consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.
P. You may request the addition and/or substitution of control materials for use with your product. Such requests will be made in consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.
Q. You may request the addition and/or substitution of other ancillary reagents and materials for use with your product. Such requests will be made in consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.
R. You will evaluate the analytical limit of detection and assess traceability7 of your product with any FDA-recommended reference material(s). After submission to FDA and DMD/OHT7-OIR/CDRH’s review of and concurrence with the data, You will update its labeling to reflect the additional testing. Such labeling updates will be made in consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.
S. You will complete the agreed upon bridging study to add at least one addition extraction method(s) to your product within 15 days of the date of this letter. After submission to FDA and DMD/OHT7-OIR/CDRH’s review of and concurrence with the data, you will update its labeling to reflect the additional extraction method(s). Such labeling updates will be made in consultation with, and require concurrence of, DMD/OHT7- OIR/OPEQ/CDRH.
T. You will track adverse events, including any occurrence of false results and report to FDA under 21 CFR Part 803.
Authorized Laboratories
U. Authorized laboratories using your product will include with result reports of your product, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media.
V. Authorized laboratories using your product will use your product as outlined in the
7 Traceability refers to tracing analytical sensitivity/reactivity back to an FDA-recommended reference material.
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Instructions for Use. Deviations from the authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use your product are not permitted.
W. Authorized laboratories that receive your product will notify the relevant public health authorities of their intent to run your product prior to initiating testing.
X. Authorized laboratories using your product will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate.
Y. Authorized laboratories will collect information on the performance of your product and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA- Xxxxxxxxx@xxx.xxx.xxx) and You (xxxxxxx@xxxxxxxxxxxx.xx.xx) any suspected occurrence of false positive or false negative results and significant deviations from the established performance characteristics of your product of which they become aware.
Z. All laboratory personnel using your product must be appropriately trained in RT-PCR techniques and use appropriate laboratory and personal protective equipment when handling this kit, and use your product in accordance with the authorized labeling.
Primerdesign Ltd (You), Authorized Distributors and Authorized Laboratories
AA. You, authorized distributors, and authorized laboratories using your product will ensure that any records associated with this EUA are maintained until otherwise notified by FDA. Such records will be made available to FDA for inspection upon request.
Conditions Related to Advertising and Promotion
BB. All advertising and promotional descriptive printed matter relating to the use of your product shall be consistent with the Fact Sheets and authorized labeling, as well as the terms set forth in this EUA and the applicable requirements set forth in the Act and FDA regulations.
CC. All advertising and promotional descriptive printed matter relating to the use of your product shall clearly and conspicuously state that:
• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an EUA for use by authorized laboratories;
• This test has been authorized only for the detection of nucleic acid from SARS- CoV-2, not for any other viruses or pathogens; and
Page 8 – Xxxxx Xxxxx-Xxxxx, Primerdesign Ltd
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21
U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
No advertising or promotional descriptive printed matter relating to the use of your product may represent or suggest that this test is safe or effective for the detection of SARS-CoV-2.
The emergency use of your product as described in this letter of authorization must comply with the conditions and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.
Sincerely,
XXXX Xxxxxx X. Xxxxxx Chief Scientist
Food and Drug Administration
Enclosures
The Novacyt Group is an international diagnostics business generating an increasing portfolio of in vitro and molecular diagnostic tests. Its core strengths lie in diagnostics product development, commercialisation, contract design and manufacturing. The Company's lead business units comprise of Primerdesign and Lab21 Products, supplying an extensive range of high-quality assays and reagents worldwide. The Group directly serves microbiology, haematology and serology markets as do its global partners, which include major corporates.
For more information please refer to the website: xxx.xxxxxxx.xxx About COVID-19
Researchers at the Chinese Centre for Disease Control and Prevention and their
collaborators have sequenced the 2019 novel coronavirus (COVID-19) pathogen from patient samples and have found it to be genetically distinct from the severe acute respiratory syndrome (SARS) virus that caused an epidemic in 2002 and 2003, as well as from the Middle East respiratory syndrome (MERS) virus that was detected in 2012.
Page 2 of 2
Novacyt S.A. ("Novacyt" or the "Company")
COVID-19 test eligible for WHO Emergency Use Listing
Paris, France and Camberley, UK – 8 April 2020 – Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that its test for COVID- 19 (Z-Path COVID-19-CE IVD) has been listed as eligible for World Health Organization (WHO) procurement under the WHO Emergency Use Listing (EUL) process. The test will be eligible for procurement for one year, unless circumstances dictate otherwise. The test has been developed by Novacyt’s molecular diagnostics division, Primerdesign, based in Southampton, UK.
The EUL is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency. It will assist interested UN procurement agencies and Member States in determining the acceptability of using specific products, based on an essential set of available quality, safety, and efficacy and performance data. The procedure is a key tool for companies wishing to submit their products for use during health emergencies.
Xxxxxx Xxxxxx, Chief Executive Officer of Novacyt, commented:
“The Emergency Use Listing by the WHO importantly provides further validation of our COVID- 19 test and gives government agencies around the world further confidence in the effectiveness of our test.”
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.
- End –
Contacts Novacyt XX
Xxxxxx Xxxxxx, Chief Executive Officer Xxxxxxx Xxxx, Chief Financial Officer
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SP Angel Corporate Finance LLP (Nominated Adviser and Broker)
Xxxxxxx Xxxxxxx / Xxxxxxx Xxxxxxxx (Corporate Finance) Xxxxx Xxxxxxxxx / Xxx Xxxx (Corporate Broking)
x00 (0)00 0000 0000
FTI Consulting (International)
Xxxxxxxx Xxxxxx Xxxxxxxx / Xxxx Xxxxxxx
x00 (0)00 0000 0000
xxxxxxxx.xxxxxxxxxxxxxx@xxxxxxxxxxxxx.xxx / xxxx.xxxxxxx@xxxxxxxxxxxxx.xxx
FTI Consulting (France)
Xxxxxx xx Xxxxxxxxxxxxx
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xxxxxx.xxxxxxxxxxxxxxx@xxxxxxxxxxxxx.xxx
About Novacyt Group
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Antipandemic System
C A B I N E D I D I S I N F E Z I O N E
Mobile aerosol disinfection version
A01
The thermometry and disinfection integrated channel from Nokonden is used for disinfection of body, pet, goods and other objects in public space entrance when emergency public health events occur. The operation of the equipment is under intelligent control, and there is no need for special personnel to operate.
protect the environment
The equipment has many functions, such as automatic liquid feeding, real-time display of running state, automatic reaction of entry and exit objects, fog, quantity and spray time can be adjusted; equipped with casters and handles, convenient for mobile and rapid deployment; exquisite appearance, scientific and safe in design, and convenient in recycling waste liquid, and
Comes with induction, wash hands to disinfect
Advantages
1. Atomization disinfection function, comprehensive disinfection to ensure safety
2. Non-contact alcohol sterilizer specially for hand using to avoid crossing infection
3. Sole disinfection
4. Stable control disinfectant quantity to ensure disinfection effect
5. Reminder of equipment status
6. Automatic fluid infusion & Waste liquid collection
7. Illumination of the channel with 24 hours using
8. Universal casters with brakes, Movable
9. Original patent & Attractive appearance
Patent Application No. 202030053956.4 202020183189.3
Type
A01
Working
environment
10-40°C
(Unusable below 0 degrees, disinfectant freezes
and cannot be atomazied)
Spray
efficiency
1-3Kg/H
Size
L180*W110*H241cm
Inner
channel size
L180*W100*H197cm
Spray area
protection method
Magnetic PVC curtain
Working
Voltage
AC220V
Disinfection
type
Automatic induction
spray
Spray
disinfection waiting time
5-15 seconds
recommended
(Stay according to personal needs, the device does not make mandatory control)
Rated
power
900 W
The length of
spray channel
116cm
Disinfectant
type
100-400PPM diluted
solution of chlorine dioxide, 200PPM diluted solution
of hypochlorous acid
Equipment
material
Cold rolled
steel plate
Fog making
way
Ultrasonic
atomizing
Disinfection
tank capacity
15L
Rainproof
function
Equipment housing
with rain protection
(Open access doors are not rainproof)
Spray control
method
Microwave induction start,
delay stop
(Delay adjustable: 5.60 seconds)
2 fog outlets
Hand
disinfection type
Independent area
induction spray type, disposable disinfectant
Shandong Nokonden Anti epidemic Equipment Co., Ltd.
Nokonden is a wholly-owned subsidiary of Shandong JEKEEN Intelligent Manufacturing Technology Co., Ltd., focusing on the research and development and manufacturing of anti epidemic equipment such as temperature measurement, disinfection, and mobile medical space.
The company has an intelligence factory of 60,000 m² and a R&F team of 100 people. Relying on its strong R&D and manufacturing capabilities, it has developed dozens of products such us temperature measurement channels, disinfection channels, and medical cabins. It provides safe, accurate and flexible ant- epidemic equipment solutions for all kinds of public places, such as schools, hospitals, communities, enterprises and institutions, public transportation, and leisure places, etc.
Antipandemic System
S i s t e m i d i t r a c c i a m e n t o t e m p e r a t u r a c o r p o r e a
di misurazione istantanea della temperatura corporea
ACCURATEZZA DELLA MISURAZIONE ± 0.3°C
di misurazione istantanea della temperatura corporea
ACCURATEZZA DELLA MISURAZIONE ± 0.3°C
KIT BASE
JQ-D70Z
Meglio conosciuto come «Blackbody» è uno strumento certificato che, inserito xxx xxxxx di ripresa, fornisce un riferimento di temperatura costante e preciso che la telecamera sfrutta per auto calibrarsi e aumentare l’accuratezza della misurazione.
TPC-BF3221-TB7F8
Telecamera ibrida con misurazione della temperatura che fornisce simultaneamente un’immagine normale e una termica xxxxx xxxxx ripresa. Un algoritmo di intelligenza artificiale riconosce le figure umane e permette di misurare la temperatura del volto, escludendo qualsiasi altra fonte di xxxxxx xxx possa costituire un falso allarme, alla distanza ottimale di 3 metri.
NVR5X-I
Registra il video e aggiunge la possibilità di generare un evento se una delle persone inquadrate ha il volto coperto, per esempio da una mascherina, fino a 4 canali.
IVSS7X
Registra il video e aggiunge la possibilità di generare un evento se una delle persone inquadrate ha il voltocoperto, per esempio, da una mascherina, fino a 8 canali.
PRODOTTI OPZIONALI
CENTER330
Server & Workstation compatta con Win10Pro x64.
RAW021-00
Adattatore cavalletto/telecamera, cavalletto/blackbody
VTC-990
Cavalletto tripod per telecamera/ blackbody
ACCESSORI
SWP1220
Alimentatore 12 VDC/2A per telecamera
Sistema di misurazione
base
Tramite l’interfaccia web della telecamera è possibile visualizzare in tempo xxxxx la temperatura rilevata e agire di conseguenza, avviando, per esempio, la comunicazione bidirezionale verso il microfono e lo speaker integrati nella telecamera al fine di separare il soggetto dalla folla. Al superamento xxxxx xxxxxx di temperatura è possibile attivare il led xxxxxx intermittente e/o riprodurre un messaggio audio dallo speaker.
Blackbody
Telecamera Ibrida
Web page
multi-punto
I vari punti di rilevazione vengono centralizzati sulla workstation tramite il software DSS Express. I vantaggi
rispetto alla soluzione base sono:
•Centralizzazione di più punti di
ì
•Mappa grafica
misurazione, in rete locale o da remoto
•Ricezione evento con messaggio di notifica, allarme sonoro e finestra pop- up del xxxxxx interessato
•Possibilità di linkare l’evento di un
xxxxxx a un altro (es.: la rilevazione di temperatura anomala di un xxxxxx può essere linkata alla chiusura dell’uscita di
allarme di un altro dispositivo)
Sistema di misurazione
Blackbody
Telecamera Ibrida
Network
Blackbody
Telecamera Ibrida
Workstation
multi-punto con archiviazione e metadati
I vari punti di rilevazione vengono centralizzati sulla workstation tramite il software DSS Express. I vantaggi rispetto alla soluzione precedente
sono:
•Rilevamento di volti coperti (fino a 4 canali con NVR5-I, fino a 8 canali con IVSS-1I)
•Archiviazione delle immagini
NYR o IYSS
Sistema di misurazione
Blackbody
Telecamera Ibrida
Network
Blackbody
Telecamera Ibrida
Blackbody
Telecamera Ibrida
Workstation
Thermal Network Value Hybrid Bullet Camera
• 256x192 VOx uncooled thermal sensor technology
• Athermalized Lens (thermal camera), Focus-free
• 1/2.8” 2Megapixel progressive scan Sony cmos
• Support ROI, Motion Detection, Color Palettes
• Support measure body temperature,
• Measurement Accuracy: Max (±0.3°C, with black-body)
• Active deterrence with white light & siren
• Built-in 2/2 alarm in/out
• Micro SD memory, IP67, XxX
System Overview
Featuring a dual lens, fixed bullet camera, this series provides an all-in-one solution for capturing video surveillance for indoor and outdoor applications. Together with Thermal and Visible Technology, the camera is the perfect solution for dark, small area monitoring applications. The series combines one thermal camera for monitoring in total darkness and one visible camera with Smart IR for confirming details.
Functions
Uncooled Vox Technology
Dahua thermal cameras use uncooled Vox sensor technology . Because of small size and better performance, it’s cost-effective solution for thermal security.
High Sensitivity
High thermal sensitivity(<50mK) makes cameras capture more image details and temperature difference information.
Active Deterrence
Actve deterrence is to warn offintruders actvely with white light and siren even before users are aware of the incidence. Once an intursion is detected, the white light will turn on and the siren will buzzer to alert the intruder. The white light and the content of siren is confgurable.
Video | |
Compression | H.265/H.264/M5PEG |
Frame Rate | Main Stream: Thermal: 1280‡960/1024‡768/640‡480/256‡192@25fps Visible: 1080P (default)/720P@25fps |
Sub Stream: Thermal: 640‡480/256‡192@25fps Visible: CIF(default)/D1@25fps | |
Bit Rate Control | CBR/VBR |
Bit Rate | H.264: 640 ~ 8192Kbps |
DayƒNight | Auto(ICR)/Color/B/W |
BLC Mode | BLC/HLC/WDR |
White Balance | Auto, Manual |
Noise Reduction | Ultral DNR |
Motion Detetion | Off/On (4 zone, Rectangle) |
Region of Interest | Off/On (4 zone) |
Electronic Image Stabilization (EIS) | NA |
Defog | Off/On |
Flip | 180˚ |
Mirror | Off/On |
Privacy Masking | Off/On (4 area, Rectangle) |
Thermal Camera | |
Image Sensor | Uncooled VOx Microbolometer |
Effective Pixels | 256(H)x192(V) |
Pixel Size | 12um |
Thermal Sensitivity (NETD) | <50mK@f/1.1 |
Spectral Range | 8~14um |
Image Setting | Brightness/Sharpness/ROI/AGC/FFC/3D DNR |
Color Palettes | 18(Whitehot/Blackhot/Ironrow/Icefire/ Fusion/Rainbow/Globow/Iconbow1/ Iconbow2 .etc) |
Thermal Lens | |
Lens Type | Fixed |
Focus Control | Athermalized, Focus−free |
Focal Length | 7.1mm |
Angle of View | H: 24˚ V: 18˚ |
Visible Camera
Image Sensor | 1/2.8" 2M CMOS |
Effective Pixels | 1920(H)x1080(V) |
Electronic Shutter Speed | 1/1 ~ 1/30,000s |
Min. Illumination | Color: 0.002Lux; B/W: 0.0002Lux; 0Lux (IR on) |
IR Distance | 35m |
IR OnƒOff Control | Auto/Manual |
IR LEDs | 1 |
Visible Lens
Focal Length | 8mm |
Max Aperture | F1.9 |
Angle of View | H: 40˚ V: 22˚ |
Temperature Measurement
Measurement Range | 30˚C ~+45˚C |
Measurement Accuracy | Max (±0.3˚C, ±0.3%) with black−body Max (±1˚C, ±1%) without black−body |
Measurement Mode | Spot/Line/Area |
Measurement Rule | Spot: 12 Line: 12 Area: 12 Support 12 rules simultaneously |
Technical Specification
Audio | |
Compression | G.711a/G.711Mu/AAC |
Network | |
Ethernet | R5−45 (10/100Base−T) |
Protocol | IPv4/IPv6, HTTP, HTTPS, SSL, TCP/IP, UDP, UPnP, ICMP, IGMP, SNMP, RTSP, RTP, SMTP, NTP, DHCP, DNS, PPPOE, DDNS, FTP, IP Filter, QoS, Bonjour, 802.1x |
Interoperability | ONVIF Profile S & G, API |
Streaming Method | Unicast/Multicast |
Max. User Access | 10 Users/20 Users |
Edge Storage | Micro SD (128GB) Memory status display (Normal/Error/Active/ Formatting/Lock), NAS (Network Atached Storage), Local PC for instant recording |
Web Viewer | <IE11, <Chrome45, <Firefox52 |
Management Software | Smart PSS, DSS |
Smart Phone | Android, IOS |
Certification | CE (EN 60950:2000) FCC (FCC Part 15 SubpartB ) |
Interface | |
Video Interface | 1.0Vp−p/75▲, PAL/NTSC (HDCVI Optional) |
Audio Interface | In/Out 1/1 |
RS485 | Support |
Alarm | 2/2 In/Out |
Certifications
Ordering Information | ||
Type | Part Number | Description |
TPC-BF3221-T | TPC−BF3221P−TB7F8 | Thermal: 256x192 7mm lens Visible: 2MP 8mm lens |
Dimensions (mm) | ||
Electrical
Power Supply | DC 12V/XxX |
Power Consumption | 12W (Max) |
Environmental
Operating Condition | 10˚C ~ +35˚C |
Strorage Conditions | 10˚C ~ +35˚C/Less than 95% RH |
Ingress Protection | IP67 |
Construction
291.0[11.46"]
192.5[7.58"]
97.2[3.83"]
103.8[4.09"]
Casing | Metal |
Dimensions | 279.9mm × 103.8mm× 95.8mm(With bracket) |
Weight | ＜ 1.4Kg |
Technical Specification
G r a z i e