Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
INFLUENZA A AND /OR B - RT & POC
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-WHATOFLU5J
- Basic UDI-DI Code
- B-WHATOFLU5J
- Reference
- WH-AT-OFLU
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- W.H.P.M. Bioresearch & Technology Co., Ltd.
Additional Description
The Flu A+B Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from Influenza A and B in nasopharyngeal（NP）, anterior nasal(NS) andoropharyngeal(OS) swabs specimens in patients with signs and symptoms of respiratory infection. The Flu A+B Antigen Rapid Test is a differentiated test, such that influenza A antigens can be distinguished from influenza B antigens from a single processed sample using a single device. The test is not intended to detect influenza C antigens.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099004 | INFLUENZA A AND /OR B - RT & POC |
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