Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Chemtrue ® COVID-19/Influenza A+B/RSV Antigen Combo Rapid Test (Colloidal Gold)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-CNM0000180720004LU
- Basic UDI-DI Code
- B-CNM0000180720004LU
- Reference
- 8043C
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Shanghai Chemtron Biotech Co., Ltd.
Additional Description
The Chemtrue ® COVID-19/Influenza A+B/RSV Antigen Combo Rapid Test (Colloidal Gold) utilizes indirect immunoassay to detect nucleocapsid protein antigen of COVID-19, influenza A antigen (H1N1, H3N2, H7N9),influenza B antigen (Victoria, Yamagata) and RSV antigen directly from the swab specimens collected from nasopharynx.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105900299 | INFECTIOUS IMMUNOLOGY - OTHER |
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