VIROLOGY - RT & POC - OTHER
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- Primary DI
- 06950917930348
- Basic UDI-DI Code
- B-06950917930348
- Reference
- C011932
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Triplex International Biosciences (China) Co., LTD.
Additional Description
This SARS-CoV-2 & Flu A+B Antigen Combo Rapid Test Kit is only used for rapid in vitro qualitative detection of SARS-CoV-2, influenza A and influenza B nucleoprotein antigens in the nasopharyngeal swab, nasal swab, oropharyngeal swab or saliva specimens. It is intended to aid in the rapid differential diagnosis of SARS-CoV-2, influenza A and influenza B viral infections. Negative test results do not preclude SARS-CoV-2 or influenza infections and should not be used as the sole basis for treatment or other patient management decisions.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).