Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
B. pertussis Antigen Rapid Test
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 16972698604161
- Basic UDI-DI Code
- B-16972698604161
- Reference
- P211106
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
Additional Description
B. pertussis Antigen Rapid Test is an in vitro diagnostic test based on the principle of immuno-chromatography for the qualitative detection of Bordetella pertussis antigens in human nasopharyngeal or throat swab samples. It is intended to aid in the rapid differential diagnosis of B. pertussis infections. It’s for professional use only. Any reactive specimen with the test must be confirmed with alternative testing method(s) and clinical findings. (20 tests/kit)
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090199 | BACTERIOLOGY - RT & POC - OTHER |
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