Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
2019-Novel Coronavirus, Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06970895476133
- Basic UDI-DI Code
- B-06970895476133
- Reference
- R208T050B0C2
- 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 of influenza A virus (IFA) and NS1 gene of influenza B virus (IFB) in the specimens including nasopharyngeal swab, throat swabs, broncheoalveolar lavage fluid, saliva, and sputum.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040519 | CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01] |
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