Identity
- Trade Name
- REACTION CARDS EUDAMEDOxoid Reaction Cards FDA UDI
- Generic Name
- Microbial-isolate agglutination assay reaction card IVD FDA UDI
- Device Name
- REACTION CARDS EUDAMED
- Model / Reference
- DR0500G EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384012954 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384ReactionCards65 EUDAMED
- FDA Product Code
- GTZ FDA UDI
- EMDN Code
- W05039080 DEVICES FOR SAMPLES ANALYSES - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Microbial-isolate agglutination assay reaction card IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.3740 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Reaction Cards by Oxoid Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5032384ReactionCards65 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Oxoid Ltd
- EUDAMED SRN
- GB-MF-000016914
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED d287e21f-0d42-4262-a0e6-28208c72cc19 61 fields · synced Jul 20, 2026
- FDA UDI 5c04ddbc-b2fb-4604-a32e-b05211bcc90f 32 fields · synced May 30, 2026