Identity
- Trade Name
- LupoTek Detectin VL EUDAMEDFDA UDI
- Generic Name
- Lupus anticoagulant marker IVD, kit, clotting FDA UDI
- Device Name
- LupoTek Detectin VL EUDAMEDVenom Screening test of LA 10 x 2 ml FDA UDI
- Model / Reference
- 85-202 EUDAMEDFDA UDI
- Description
- Venom Screening test of LA 10 x 2 ml FDA UDI
Identifiers
- Catalog Number
- 85-202 FDA UDI
- Primary DI / UDI-DI
- 10859394006108 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10859394006108 EUDAMED
- 510(k) Number
- K083878 FDA UDI
- FDA Product Code
- GIR FDA UDIGGC FDA UDI
- EMDN Code
- W0103020606 LUPUS ANTICOAGULANT EUDAMED
- GMDN Term
- Lupus anticoagulant marker IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 864.8950 FDA UDI864.5425 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Prescription Use
No
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
LupoTek Detectin VL by R2 Diagnostics, Inc. — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- Lupus Anticoagulant Confirmation Reagent — Bio/Data Corp. · Class II
- CRYOcheck Hex LA — Precision Biologic · Class II
- DVVconfirm 5 — Biomedica ADI Inc. · Class I
- TriniCLOT Lupus Confirm — TCOAG IRELAND LIMITED · Class I
Cleared under the same submission
K083878 also covers:
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- R2 Diagnostics, Inc.
Sources (2)
- FDA UDI 6c341e85-5c09-4218-8acd-2e7656994d29 35 fields · synced Jul 19, 2026
- EUDAMED 6eb32db4-b3ed-45f9-b097-34c65a47fce0 61 fields · synced Jul 19, 2026