Identity
- Trade Name
- CRYOcheck Hex LA FDA UDI
- Generic Name
- Lupus anticoagulant marker IVD, kit, clotting FDA UDI
- Device Name
- CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. CRYOcheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations. FDA UDI
- Model / Reference
- Hex LA FDA UDI
- Description
- CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. CRYOcheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations. FDA UDI
Identifiers
- Catalog Number
- Hex LA FDA UDI
- Primary DI / UDI-DI
- 00843876000510 FDA UDI
- 510(k) Number
- K193556 FDA UDI
- FDA Product Code
- GFO FDA UDI
- GMDN Term
- Lupus anticoagulant marker IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7925 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
No
FDA UDI
Category: Lupus anticoagulant marker IVD, kit, clotting
CRYOcheck Hex LA by Precision Biologic — 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
- Lupus Anticoagulant Confirmation Reagent — Bio/Data Corp. · 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
- TriniCHECK™ Lupus Positive Control — TCOAG IRELAND LIMITED · Class II
- LupoTek Detectin VL — R2 DIAGNOSTICS, INC. · Class I
Cleared under the same submission
K193556 also covers:
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 |
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Manufacturer
- Manufacturer
- Precision Biologic
Sources (1)
- FDA UDI 6a2ba809-559c-4f68-822e-f9d7835210c1 35 fields · synced Jun 8, 2026