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Pathodxtra Strep Group A Latex
EUDAMEDFDA UDIClass C (EU MDR)
Ref DR0701G
by Oxoid Ltd
Identity
- Trade Name
- PATHODXTRA STREP GROUP A LATEX EUDAMEDFDA UDI
- Generic Name
- Beta-haemolytic Streptococcus serological grouping IVD, reagent FDA UDI
- Device Name
- PATHODXTRA STREP GROUP LATEX EUDAMED
- Model / Reference
- DR0701G EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384519835 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384PathoDxtraLatexTL EUDAMED
- FDA Product Code
- GTZ FDA UDI
- EMDN Code
- W0105011101 STREPTOCOCCAL DIRECT ANTIGEN DETECTION EUDAMED
- GMDN Term
- Beta-haemolytic Streptococcus serological grouping IVD, reagent 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Pathodxtra Strep Group A Latex 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 | 5032384PathoDxtraLatexTL | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | 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 77376fd9-0e29-4f5e-bc15-6ee3d1cbf467 61 fields · synced Jul 16, 2026
- FDA UDI 7d689077-0966-4e36-b072-ce999a502352 32 fields · synced May 30, 2026