Identity
- Trade Name
- EXTRACTION ENZYME EUDAMEDFDA UDI
- Generic Name
- Beta-haemolytic Streptococcus serological grouping IVD, reagent FDA UDI
- Device Name
- EXTRACTION ENZYME EUDAMED
- Model / Reference
- DR0593G EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384013111 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384StrepGroupReagD7 EUDAMED
- FDA Product Code
- GTZ FDA UDI
- EMDN Code
- W0105900201 BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC 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
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
Extraction Enzyme 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 | 5032384StrepGroupReagD7 | 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 926f613a-8db1-43bb-9ecd-79f58a0b9f2f 61 fields · synced Jul 18, 2026
- FDA UDI 7a2c0f41-fa48-48dc-808b-5441879b4974 32 fields · synced May 30, 2026