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STA® - Liatest® Free Protein S 6
EUDAMEDFDA UDIClass B (EU MDR)
Ref 00516Model STA® - Liatest® Free Protein S
Identity
- Trade Name
- STA® - Liatest® Free Protein S 6 EUDAMEDFDA UDI
- Generic Name
- Protein S IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- STA® - Liatest® Free Protein S EUDAMED
- Model / Reference
- STA® - Liatest® Free Protein S EUDAMED00516 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03607450005165 EUDAMEDFDA UDI
- Basic UDI-DI
- 360745099PS00037E EUDAMED
- 510(k) Number
- K010963 FDA UDI
- FDA Product Code
- GGP FDA UDI
- EMDN Code
- W0103020612 FREE PROTEIN S ANTIGEN EUDAMED
- GMDN Term
- Protein S IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7290 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
STA® - Liatest® Free Protein S 6 by Diagnostica Stago — Class B — 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 | 360745099PS00037E | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Diagnostica Stago
- EUDAMED SRN
- FR-MF-000017089
Sources (2)
- EUDAMED afb6a1a0-d4f6-4c84-a158-6bfd4b3f070e 61 fields · synced Aug 2, 2026
- FDA UDI 1dcf770e-7c57-407a-8ab1-80e91e82fc32 34 fields · synced May 29, 2026