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SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette - Plasma
EUDAMEDClass IVD General (EU MDR)
Ref GCCOV(NAb)-402b
Identity
- Trade Name
- SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Whole Blood/Serum/Plasma) EUDAMEDSARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) EUDAMED
- Device Name
- SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Whole Blood/Serum/Plasma) EUDAMEDSARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) EUDAMED
- Model / Reference
- GCCOV(NAb)-402b EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GCCOV(NAb)-402bCQ EUDAMEDD-GCCOV(NAb)-402bHGN8 EUDAMED
- Basic UDI-DI
- B-GCCOV(NAb)-402bCQ EUDAMEDB-GCCOV(NAb)-402bHGN8 EUDAMED
- EMDN Code
- W0105090502 CORONAVIRUS ANTIBODY (AB) - RT & POC EUDAMED
- Models / Variants
- Whole Blood EUDAMEDSerum EUDAMEDPlasma EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette - Plasma by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — 3 models
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-GCCOV(NAb)-402bCQ | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 053b967a-45dd-49ab-b5c5-605100bf67cc 61 fields · synced Oct 6, 2026
- EUDAMED 9f5dc200-3406-42d7-9807-ce308fbf06b5 61 fields · synced May 18, 2026