Identity
- Trade Name
- STA® - Deficient VII EUDAMEDFDA UDI
- Generic Name
- Coagulation factor VII IVD, kit, clotting FDA UDI
- Device Name
- STA® - Deficient VII EUDAMED
- Model / Reference
- 00743 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 13607450007432 EUDAMEDFDA UDI
- Basic UDI-DI
- B-13607450007432 EUDAMED
- 510(k) Number
- K933440 FDA UDI
- FDA Product Code
- GJT FDA UDI
- EMDN Code
- W0103020205 COAGULATION FACTOR VII EUDAMED
- GMDN Term
- Coagulation factor VII IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class IVD General 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
Yes
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
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
Category: Coagulation factor VII IVD, kit, clotting
STA® - Deficient VII 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 VII IVD, kit, clotting.
- TriniCLOT™ Factor VII — TCOAG IRELAND LIMITED · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
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 f2ffb126-bf0a-46a2-b82b-3f756b560eb5 34 fields · synced Jul 14, 2026
- EUDAMED e6488704-c51e-46a0-b144-2b3d62effb7d 61 fields · synced Jul 14, 2026