Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Novel Coronavirus (SARS-CoV-2) Real-Time Multiplex RT-PCR Kit (RR-0485-02)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06971042228407
- Basic UDI-DI Code
- B-06971042228407
- Reference
- RR-0485-02
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- SHANGHAI ZJ BIO-TECH CO., LTD
Additional Description
The Novel Coronavirus (SARS-CoV-2) Real-Time Multiplex RT-PCR Kit is an in vitro diagnostic test is for manual qualitative detection of ORF 1ab, N and E genes of SARS-CoV-2 RNA in nasopharyngeal or oropharyngeal swabs and sputum specimens collected from individuals suspected of being infected with SARS-CoV-2. The kit is for aiding in the diagnosis of COVID-19 infection and it is for professional use in level 2 biosafety laboratory by laboratory personnel trained in RT-PCR.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040519 | CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01] |
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