← Back to catalogue
STA® - Staclot® dRVV Screen 2
EUDAMEDFDA UDIClass B (EU MDR)
Ref 00339Model STA® - Staclot® dRVV Screen
Identity
- Trade Name
- STA® - Staclot® dRVV Screen 2 EUDAMEDFDA UDI
- Generic Name
- Lupus anticoagulant marker IVD, kit, clotting FDA UDI
- Model / Reference
- STA® - Staclot® dRVV Screen EUDAMED00339 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 13607450003397 EUDAMEDFDA UDI
- Basic UDI-DI
- 360745099LA0004XK EUDAMED
- Unit of Use DI
- 03607450003390 EUDAMED
- 510(k) Number
- K061805 FDA UDI
- FDA Product Code
- GIR FDA UDI
- EMDN Code
- W0103020606 LUPUS ANTICOAGULANT EUDAMED
- GMDN Term
- Lupus anticoagulant marker IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 864.8950 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® - Staclot® dRVV Screen 2 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 | 360745099LA0004XK | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnostica Stago
- EUDAMED SRN
- FR-MF-000017089
Sources (2)
- EUDAMED 64bd2aa8-0ee7-488b-a7e5-fd5de383999b 61 fields · synced Jul 14, 2026
- FDA UDI 12bb32f5-e5b1-4239-a08e-e52b5199b3b0 34 fields · synced May 30, 2026