Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)
by Ustar Biotechnologies (Hangzhou) Ltd.
Ref U20223
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06973492240299 06973492240299 | Date12 Jun 2022 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)
- Model / Reference
- U20223
- Primary DI / UDI-DI
- 06973492240299
- Basic UDI-DI
- B-06973492240299
- EMDN Code
- W0105900102 Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus
- Device Class
- Class IVD General
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000014615
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No