Identity
- Trade Name
- CRYOcheck Lupus Negative Control FDA UDI
- Generic Name
- Lupus anticoagulant marker IVD, control FDA UDI
- Device Name
- Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant. FDA UDI
- Model / Reference
- CCLN-10 FDA UDI
- Description
- Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant. FDA UDI
Identifiers
- Catalog Number
- CCLN-10 FDA UDI
- Primary DI / UDI-DI
- 00843876000534 FDA UDI
- FDA Product Code
- GGN FDA UDI
- GMDN Term
- Lupus anticoagulant marker IVD, control 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
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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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, control
CRYOcheck Lupus Negative Control by Precision Biologic — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lupus anticoagulant marker IVD, control.
- LA Control Low — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- George King Positive Lupus Anticoagulant — GEORGE KING BIO-MEDICAL, INC. · Class II
- LAtrol ABNORMAL CONTROL PLASMA — Biomedica ADI Inc. · Class II
- George King Positive Lupus Anticoagulant — GEORGE KING BIO-MEDICAL, INC. · Class II
- LA Control High — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- LAtrol NORMAL CONTROL PLASMA — Biomedica ADI Inc. · Class II
- LA Control High — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- George King Positive Lupus Anticoagulant — GEORGE KING BIO-MEDICAL, INC. · Class II
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 280c5d5f-0745-40cc-b194-1c74b1f61ba2 34 fields · synced May 30, 2026