Eu Ivdd
Eu Ivd General
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🇨🇳 China
Mononucleosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-GCMON-425a7C
- Basic UDI-DI Code
- B-GCMON-425a7C
- Reference
- GCMON-425a
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
Additional Description
The Mononucleosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of 4 serologic markers of Epstein-Barr virus (EBV), two of IgM class, VCA and heterophile antibodies, and two of IgG class, VCA and EBNA, in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infectious mononucleosis. Any reactive specimen with the Mononucleosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099003 | MONONUCLEOSIS (EBV) - RT & POC |
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