Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
GENEDIAN
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-RA006UM
- Basic UDI-DI Code
- B-RA006UM
- Reference
- P122-01048
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Hangzhou DIAN Biotechnology Co., Ltd.
Additional Description
The kit is used for the qualitative detection of ORF1ab and N genes in the pharyngealswabs and sputum samples of patients such as suspected cases of New Coronavirus pneumonia, clustering cases, and those who need New Coronavirus infection diagnosis or differential diagnosis in vitro. The detection result is for use as the clinical reference only and should not be used as the sole standard for the diagnosis of SARS-COV-2, it is suggested to be used in combination with patient’s symptoms and other IVD results for accurate diagnosis and overall evaluation of disease progress.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040519 | CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01] |
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