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SARS-CoV-2 IgG/IgM Rapid Antibody Test
EUDAMEDClass IVD General (EU MDR)
Ref SFTCV
Identity
- Trade Name
- SARS-CoV-2 IgG/IgM Rapid Antibody Test EUDAMED
- Device Name
- SARS-CoV-2 IgG/IgM Rapid Antibody Test EUDAMED
- Model / Reference
- SFTCV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08697962616077 EUDAMED
- Basic UDI-DI
- B-08697962616077 EUDAMED
- EMDN Code
- W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
A reliable and fast SARS-CoV-2 IgG/IgM Rapid Antibody Test is a highly accurate diagnostic tool for detecting the presence of antibodies in patients. With its simple yet precise testing process, it helps healthcare professionals make informed decisions about patient care and treatment.
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-08697962616077 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000046897
Sources (1)
- EUDAMED 493d971b-5ddb-4935-bff1-4bfe17320dab 61 fields · synced Oct 6, 2026