Identity
- Trade Name
- RD5 RIFAMPICIN EUDAMEDNA FDA UDI
- Generic Name
- Rifampicin susceptibility testing disc IVD FDA UDI
- Device Name
- RIFAMPICIN EUDAMED
- Model / Reference
- CT0207B EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384006526 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384RifampicinHU EUDAMED
- 510(k) Number
- K971636 FDA UDI
- FDA Product Code
- JTN FDA UDI
- EMDN Code
- W0104080502 IMPREGNATED DISKS, MULTI-DISKS & TABLETS EUDAMED
- GMDN Term
- Rifampicin susceptibility testing disc IVD FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.1620 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Rd5 Rifampicin by Oxoid Ltd — Class B — 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 | 5032384RifampicinHU | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | 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 5e6940cc-b561-4f8e-96bc-9832f1f976ec 61 fields · synced Jul 9, 2026
- FDA UDI 23de3607-7763-4b7d-806a-1ff1d8c4372e 34 fields · synced May 30, 2026