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SARS-CoV-2 Ag Detection Kit (Immunofluorescence Chromatography)
EUDAMEDClass IVD General (EU MDR)
Ref GKPD149
Identity
- Trade Name
- SARS-CoV-2 Ag Detection Kit (Immunofluorescence Chromatography) EUDAMED
- Device Name
- SARS-CoV-2 Ag Detection Kit (Immunofluorescence Chromatography) EUDAMED
- Model / Reference
- GKPD149 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GKPD149XU EUDAMED
- Basic UDI-DI
- B-GKPD149XU EUDAMED
- EMDN Code
- W0105090501 CORONAVIRUS ANTIGEN (AG) - RT & POC 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
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 Ag Detection Kit (Immunofluorescence Chromatography) by Dezhou Guoke Medical Technology Co., Ltd. — 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-GKPD149XU | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dezhou Guoke Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000044128
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 4dc19535-2d0c-426e-b3b4-19bab8e50634 61 fields · synced Jun 18, 2026