Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
2019-Novel Coronavirus, Influenza Virus,Respiratory Syncytial Virus Nucleic Acid Test Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06970895476102
- Basic UDI-DI Code
- B-06970895476102
- Reference
- R213T050B0C2
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
Additional Description
This kit is intended for qualitative detection of ORF1ab gene of 2019 Novel Coronavirus (2019 nCoV, SARS COV 2), M1 gene or NS1 gene of Influenza Virus and F gene of RSV in the specimens including Oropharyngeal swabs, sputum and Bronchoalveolar lavage fluid.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040519 | CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01] |
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