Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
COVID-19 Ag Rapid Test Cassette
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06936595751758
- Basic UDI-DI Code
- B-06936595751758
- Reference
- CG2302TY1
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
Additional Description
The COVID-19 Ag Rapid Test Cassette is an immunochromatographic assay kit for the qualitative detection of SARS-CoV-2 antigen in nasopharyngeal swab, oropharyngeal swab,nasal swab and saliva from human, as an aid to early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms with SARS-CoV-2 infection. It provides only an initial screening test result. Negative results do not preclude COVID-19 infection and should not be used as the sole basis for treatment or other patient management decisions.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040519 | CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01] |
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