Identity
- Trade Name
- STA® - Staclot® dRVV Confirm FDA UDI
- Generic Name
- Lupus anticoagulant marker IVD, kit, clotting FDA UDI
- Model / Reference
- 00334 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 13607450003342 FDA UDI
- 510(k) Number
- K061805 FDA UDI
- FDA Product Code
- GIR FDA UDI
- GMDN Term
- Lupus anticoagulant marker IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.8950 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: Lupus anticoagulant marker IVD, kit, clotting
STA® - Staclot® dRVV Confirm by Diagnostica Stago, Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Lupus anticoagulant marker IVD, kit, clotting.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Diagnostica Stago, Inc.
Sources (2)
- FDA UDI d6615e15-65b3-43db-82ed-c51bda9bc156 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 5, 2026