← Back to catalogue
Polyvalent Positive Control
EUDAMEDFDA UDIClass C (EU MDR)
Ref DR0592G
by Oxoid Ltd
Identity
- Trade Name
- POLYVALENT POSITIVE CONTROL EUDAMEDFDA UDI
- Generic Name
- Beta-haemolytic Streptococcus serological grouping IVD, control FDA UDI
- Device Name
- POLYVALENT POSITIVE CONTROL EUDAMED
- Model / Reference
- DR0592G EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384013104 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384StrepGroupPC2K EUDAMED
- FDA Product Code
- GTZ FDA UDI
- EMDN Code
- W0105080801 BACTERIOLOGY CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Beta-haemolytic Streptococcus serological grouping IVD, control FDA UDI
Classification
- Device Class
- Class C 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
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
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
Polyvalent Positive Control by Oxoid Ltd — Class C — 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 | 5032384StrepGroupPC2K | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Oxoid Ltd
- EUDAMED SRN
- GB-MF-000016914
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED 75e0b19f-559d-4a74-a982-f1ce29140354 61 fields · synced Jun 19, 2026
- FDA UDI ad1482db-2f05-4956-aa7e-632f29d07aa6 32 fields · synced May 30, 2026