Identity
- Trade Name
- CRYOcheck™ LA Sure™ FDA UDI
- Generic Name
- Lupus anticoagulant marker IVD, reagent FDA UDI
- Model / Reference
- SUR-10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843876000480 FDA UDI
- 510(k) Number
- K990580 FDA UDI
- FDA Product Code
- GIR FDA UDI
- GMDN Term
- Lupus anticoagulant marker IVD, reagent 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
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, reagent
CRYOcheck™ LA Sure™ by Precision Biologic — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lupus anticoagulant marker IVD, reagent.
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- LA 2 Confirmation Reagent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- CRYOcheck™ LA Check™ — Precision Biologic · Class I
- CRYOcheck™ LA Check™ — Precision Biologic · Class I
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- CRYOcheck™ LA Check™ — Precision Biologic · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Precision Biologic
Sources (1)
- FDA UDI 30440594-0544-4203-9805-3a953d630df8 33 fields · synced Jun 8, 2026