Identity
- Trade Name
- LA Control Low FDA UDI
- Generic Name
- Lupus anticoagulant marker IVD, control FDA UDI
- Device Name
- LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays FDA UDI
- Model / Reference
- 10873569 FDA UDI
- Description
- LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays FDA UDI
Identifiers
- Catalog Number
- OQWE13 FDA UDI
- Primary DI / UDI-DI
- 00630414023502 FDA UDI
- 510(k) Number
- K993332 FDA UDI
- FDA Product Code
- GGC 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
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, control
LA Control Low by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lupus anticoagulant marker IVD, control.
- George King Positive Lupus Anticoagulant — GEORGE KING BIO-MEDICAL, INC. · Class II
- LAtrol ABNORMAL CONTROL PLASMA — Biomedica ADI Inc. · Class II
- CRYOcheck™ Lupus Positive Control — Precision Biologic · Class II
- 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
- CRYOcheck™ Lupus Positive Control — Precision Biologic · Class II
- CRYOcheck™ Weak Lupus Positive Control — Precision Biologic · Class II
Cleared under the same submission
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
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI bfca4c95-6d99-4c22-83fa-881dcae24894 37 fields · synced Jun 8, 2026