Identity
- Trade Name
- LAtrol NORMAL CONTROL PLASMA FDA UDI
- Generic Name
- Lupus anticoagulant marker IVD, control FDA UDI
- Model / Reference
- 816N FDA UDI
Identifiers
- Catalog Number
- 816N FDA UDI
- Primary DI / UDI-DI
- 00850201006147 FDA UDI
- FDA Product Code
- GIZ 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
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, control
LAtrol NORMAL CONTROL PLASMA by Biomedica ADI Inc. — 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
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- George King Positive Lupus Anticoagulant — GEORGE KING BIO-MEDICAL, INC. · Class II
- CRYOcheck Lupus Negative Control — Precision Biologic · Class II
- CRYOcheck™ Weak Lupus Positive Control — Precision Biologic · Class II
- LA Control High — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- CRYOcheck™ Lupus Positive Control — Precision Biologic · 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
- Biomedica ADI Inc.
Sources (1)
- FDA UDI 20562e22-e86b-4433-97a4-d72e176d1ddc 33 fields · synced May 30, 2026