Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
COVID-19 Nucleic Acid Rapid Test
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06975412190097
- Basic UDI-DI Code
- B-06975412190097
- Reference
- GZ-SC4
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Shanghai GeneSc Biotech Co., Ltd.
Additional Description
This kit is used for in vitro qualitative and rapid detection of novel coronavirus (2019-nCoV) ORF1ab gene in nasopharyngeal swab samples from suspected cases of novel coronavirus pneumonia, suspected cluster cases and those requiring the diagnosis or differential diagnosis of novel coronavirus infection. This kit is intended for professional in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01050499 | VIROLOGY REAGENTS - OTHER |
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