Novel Coronavirus 2019-nCoV Rapid Detection Kit (LAMP)
Basic Information
- Primary DI
- 06975412190073
- Basic UDI-DI Code
- B-06975412190073
- Reference
- GZ-OX96
- 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. The definitions of "suspected cases", "cluster cases", etc. shall be given with reference to the Scheme for the Diagnosis and Treatment of Novel Coronavirus Pneumonia, the Scheme for the Prevention and Control of Novel Coronavirus Pneumonia and other documents. Its usage shall comply with the relevant requirements in the Scheme for the Diagnosis and Treatment of Novel Coronavirus Pneumonia, the Scheme for the Prevention and Control of Novel Coronavirus Pneumonia and other documents. Novel coronavirus nucleic acid detection should meet the requirements in the Technical Guidelines for Laboratory Detection of Novel Coronavirus Pneumonia for biosafety.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01050499 | VIROLOGY REAGENTS - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).