Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Novel Coronavirus (2019-nCOV) Antigen Rapid Test Cassette (swab)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06976753473252
- Basic UDI-DI Code
- B-06976753473252
- Reference
- A211301D
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Hangzhou Cybereagen Biotech Co., Ltd.
Additional Description
"This kit is used for in vitro qualitative detection of new coronavirus infection in suspected cases of pneumonia, patients with suspected clusters of cases, and other nasal swabs and throat swab samples from patients who need to diagnose or differentially diagnose new coronavirus infections. 2019-nCoV) antigen. It is used to assist in the diagnosis of new coronavirus infection and cannot be used as the basis for the diagnosis and exclusion of pneumonia caused by new coronavirus infection."
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
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