Identity
- Trade Name
- Autoimmune EIA FDA UDI
- Generic Name
- Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Autoimmune EIA Anti-Cardiolipin IgM Test Kit FDA UDI
- Model / Reference
- 425-2020 FDA UDI
- Description
- Autoimmune EIA Anti-Cardiolipin IgM Test Kit FDA UDI
Identifiers
- Catalog Number
- 425-2020 FDA UDI
- Primary DI / UDI-DI
- 00847817018213 FDA UDI
- 510(k) Number
- K032868 FDA UDI
- FDA Product Code
- MID FDA UDIDHC FDA UDIMSV FDA UDI
- GMDN Term
- Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 FDA UDI866.5820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Category: Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA).
- REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit (96-Well) — CORGENIX MEDICAL CORPORATION · Class II
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- QUANTA Lite® ACA IgA III — INOVA DIAGNOSTICS, INC. · Class II
- Cardiolipin IgM ELISA — DRG International, Inc. · Class II
- REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit (96 Well) — CORGENIX MEDICAL CORPORATION · Class II
Cleared under the same submission
K032868 also covers:
- Autoimmune EIA — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Corgenix Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (192 Well) — CORGENIX MEDICAL CORPORATION
- Corgenix Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit (192 Well) — CORGENIX MEDICAL CORPORATION
- Corgenix Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (192 Well) — CORGENIX MEDICAL CORPORATION
- Corgenix Anti-Cardiolipin IgA Semi-Quantitative Test Kit (192 Well) — CORGENIX MEDICAL CORPORATION
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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 3b923bb5-e4ec-4be1-a1a5-71e108d26f04 38 fields · synced May 30, 2026