Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06936595752243
- Basic UDI-DI Code
- B-06936595752243
- Reference
- CG2301Y
- 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 IgM/IgG Antibody (IgM/IgG) Combined Test Kit is a rapid chromatographic immunoassay for the qualitative detection of IgM&IgG antibody to SARS-CoV-2 in human serum, plasma or whole blood as an aid in the diagnostic of COVID-19 infections. 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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