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SARS-CoV-2 Antigen Kit (Colloidal Gold) (for self-testing)
EUDAMEDClass IVD General (EU MDR)
Ref CG123001
Identity
- Trade Name
- SARS-CoV-2 Antigen Kit (Colloidal Gold) (for self-testing) EUDAMED
- Device Name
- SARS-CoV-2 Antigen Kit (Colloidal Gold) (for self-testing) EUDAMED
- Model / Reference
- CG123001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971225931650 EUDAMED
- Basic UDI-DI
- B-06971225931650 EUDAMED
- EMDN Code
- W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SARS-CoV-2 Antigen Kit (Colloidal Gold) (for self-testing) by Goldsite Diagnostics Inc. — Class IVD General — IVDD — listed in EUDAMED
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-06971225931650 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Goldsite Diagnostics Inc.
- EUDAMED SRN
- CN-MF-000001353
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED cd3e1c9a-8ff4-4818-aa76-6a63a633f467 61 fields · synced Jun 19, 2026