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Clarity Uti / Staph-Strep Cna (modified) Bi-Plate
EUDAMEDClass A (EU MDR)
Ref PB1155E
by Oxoid Ltd
Identity
- Trade Name
- CLARITY UTI / STAPH-STREP CNA (MODIFIED) BI-PLATE EUDAMED
- Device Name
- CLARITY UTI / STAPH-STREP CNA (MODIFIED) BI-PLATE EUDAMED
- Model / Reference
- PB1155E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032384170371 EUDAMED
- Basic UDI-DI
- 5032384UTIStaphStrep2J EUDAMED
- EMDN Code
- W0104010407 BI-PLATES - INCLUDING NON-CHROMOGENIC & CHROMOGENIC MEDIA COMBINATION EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Clarity Uti / Staph-Strep Cna (modified) Bi-Plate by Oxoid Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5032384UTIStaphStrep2J | Class A | Active |
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Manufacturer
- Manufacturer
- Oxoid Ltd
- EUDAMED SRN
- GB-MF-000016914
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (1)
- EUDAMED 476882d0-45bc-443a-b115-224e4a90d18f 61 fields · synced Jul 8, 2026