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Pathodxtra Extraction Reagents
EUDAMEDFDA UDIClass C (EU MDR)
Ref DR0709M
by Oxoid Ltd
Identity
- Trade Name
- PATHODXTRA EXTRACTION REAGENTS EUDAMEDFDA UDI
- Generic Name
- Beta-haemolytic Streptococcus serological grouping IVD, reagent FDA UDI
- Device Name
- PATHODXTRA EXTRACTION REAGENTS EUDAMED
- Model / Reference
- DR0709M EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384519569 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384PathoDxtraReagJQ EUDAMED
- FDA Product Code
- GTZ FDA UDI
- EMDN Code
- W0105011199 STREPTOCOCCAL REAGENTS - OTHER 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
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
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 Extraction Reagents 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 | 5032384PathoDxtraReagJQ | 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 f5077b0b-c74a-4901-9f89-f8d6d00f86cb 61 fields · synced Jul 11, 2026
- FDA UDI 3d61d83b-c862-4433-befd-408bd665a0b1 32 fields · synced May 30, 2026