Identity
- Trade Name
- Lupus Anticoagulant Confirmation Reagent FDA UDI
- Generic Name
- Lupus anticoagulant marker IVD, kit, clotting FDA UDI
- Model / Reference
- 102516 FDA UDI
Identifiers
- Catalog Number
- 102516 FDA UDI
- Primary DI / UDI-DI
- G0561025161 FDA UDI
- FDA Product Code
- JPA FDA UDI
- GMDN Term
- Lupus anticoagulant marker IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Category: Lupus anticoagulant marker IVD, kit, clotting
Lupus Anticoagulant Confirmation Reagent by Bio/Data Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lupus anticoagulant marker IVD, kit, clotting.
- TriniCLOT Lupus Screen — TCOAG IRELAND LIMITED · Class I
- DVVtest 25 — Biomedica ADI Inc. · Class I
- CRYOcheck Hex LA — Precision Biologic · Class II
- CRYOcheck Hex LA — Precision Biologic · Class II
- CRYOcheck Hex LA — Precision Biologic · Class II
- DVVconfirm 5 — Biomedica ADI Inc. · Class I
- TriniCLOT Lupus Confirm — TCOAG IRELAND LIMITED · Class I
- STA® - Staclot® dRVV Confirm — DIAGNOSTICA STAGO, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Bio/Data Corp.
Sources (1)
- FDA UDI 588e7d5c-aad4-476b-b89d-8ec8716e4a5d 33 fields · synced May 31, 2026