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RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab)
EUDAMEDClass IVD General (EU MDR)
Ref FCRA-T502a
Identity
- Trade Name
- RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab) EUDAMED
- Device Name
- RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab) EUDAMED
- Model / Reference
- FCRA-T502a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FCRA-T502aZK EUDAMED
- Basic UDI-DI
- B-FCRA-T502aZK EUDAMED
- EMDN Code
- W0105070399 MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab) by Zhejiang Orient Gene Biotech 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-FCRA-T502aZK | 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 (1)
- EUDAMED 818e1599-390e-48f4-9cd3-bcd9571db8fb 61 fields · synced Oct 6, 2026