Identity
- Trade Name
- STA® - Deficient II EUDAMEDFDA UDI
- Generic Name
- Coagulation factor II (prothrombin) IVD, kit, clotting FDA UDI
- Device Name
- STA® - Deficient II EUDAMED
- Model / Reference
- 00745 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 13607450007456 EUDAMEDFDA UDI
- Basic UDI-DI
- B-13607450007456 EUDAMED
- 510(k) Number
- K934606 FDA UDI
- FDA Product Code
- GJS FDA UDIGJT FDA UDI
- EMDN Code
- W0103020202 COAGULATION FACTOR II ( PROTHROMBIN ) EUDAMED
- GMDN Term
- Coagulation factor II (prothrombin) IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7750 FDA UDI864.7290 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
Yes
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Coagulation factor II (prothrombin) IVD, kit, clotting
STA® - Deficient II by Diagnostica Stago, Inc. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Coagulation factor II (prothrombin) IVD, kit, clotting.
- TriniCLOT™ Factor II — TCOAG IRELAND LIMITED · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnostica Stago, Inc.
Sources (2)
- FDA UDI b230e0c4-cfe0-4bbf-bcb5-09f29a200692 34 fields · synced Jul 26, 2026
- EUDAMED 2c12fa65-38ac-451c-9f97-1edb45c0c81d 61 fields · synced Jul 26, 2026