Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
SARS-CoV-2 (ORF1ab, N and 211-212del) Detection Kit (Fluorescence PCR)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06974849366457
- Basic UDI-DI Code
- B-06974849366457
- Reference
- HWTS-RT104A
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Additional Description
The kit is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection of the oropharyngeal swab and nasopharyngeal swab of the related cases during the novel coronavirus (SARS-CoV-2)-infected pneumonia epidemic. The ORF1ab gene, N gene and the mutation site 211-212del which called "Omicron" mutant strain were tested.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010699 | GENETIC TESTS - OTHER |
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