Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
2019-Novel Coronavirus Mutants 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
- 06970895476188
- Basic UDI-DI Code
- B-06970895476188
- Reference
- R401T001B0C2
- 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 ORF genes of 2019-Novel Coronavirus (2019-nCoV, SARS-COV-2) and mutants including B.1.1.7(α), B.1.351(β), P.1(γ), B.1.617.2(δ), B.1.617.1(κ), B.1.525(η) and B.1.620 in the specimens including nasopharyngeal swab, oropharyngeal swabs, bronchoalveolar lavage fluid, saliva, sputum and fecal.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040519 | CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01] |
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