Identity
- Trade Name
- PATHODX STREP GROUPING UNIVERSAL KIT EUDAMEDPathoDx Strep Grouping Universal Kit (120 test) FDA UDI
- Generic Name
- Beta-haemolytic Streptococcus serological grouping IVD, reagent FDA UDI
- Device Name
- PATHODX STREP GROUPING UNIVERSAL KIT EUDAMED
- Model / Reference
- R62150 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056080501369 EUDAMEDFDA UDI
- Basic UDI-DI
- 50560805PathDXStrepC7 EUDAMED
- 510(k) Number
- K871831 FDA UDI
- 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Pathodx Strep Grouping Universal Kit by Remel Europe 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 | 50560805PathDXStrepC7 | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- Remel Europe Ltd
- EUDAMED SRN
- GB-MF-000016733
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED ab4a14cb-c631-472e-bac3-60f35bff7511 61 fields · synced Jun 19, 2026
- FDA UDI 95fd2aad-f03d-42e3-adac-e7888750dd16 34 fields · synced May 29, 2026