Eu Ivdd
Eu Ivd General
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🇨🇳 China
Mononucleosis 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-402a6R
- Basic UDI-DI Code
- B-GCMON-402a6R
- Reference
- GCMON-402a
- 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 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis lgM heterophile antibodies in whole blood, serum and plasma. This test is intended for use as an aid in the diagnosis of Infectious Mononucleosis. It is for professional in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099003 | MONONUCLEOSIS (EBV) - RT & POC |
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