Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
SARS-CoV-2 Realtime PCR Test Kit (Lyophilized)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06970895476379
- Basic UDI-DI Code
- B-06970895476379
- Reference
- R20508T2100
- 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, E & N genes of 2019-Novel Coronavirus (2019-nCoV, SARS-COV-2) in the specimens including nasopharyngeal swab, oropharyngeal swab and sputum. The ORF1ab gene sequences are higher specificity for 2019-nCoV, while the sequences of the E and N genes are homogenous to the same genes in some viruses such as SARS-like coronaviruses and coronaviruses carried by some bats. For professional in-vitro diagnostic use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040519 | CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01] |
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