Identity
- Trade Name
- Anti-Cardiolipin IgA ELISA FDA UDI
- Generic Name
- Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Anti-Cardiolipin IgA ELISA is a test system for the quantitative measurement of IgA class autoantibodies against cardiolipin in human serum or plasma FDA UDI
- Model / Reference
- EIA-3588 FDA UDI
- Description
- Anti-Cardiolipin IgA ELISA is a test system for the quantitative measurement of IgA class autoantibodies against cardiolipin in human serum or plasma FDA UDI
Identifiers
- Catalog Number
- EIA-3588 FDA UDI
- Primary DI / UDI-DI
- 04048474035889 FDA UDI
- 510(k) Number
- K962469 FDA UDI
- FDA Product Code
- MID 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 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
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
Yes
FDA UDI
Category: Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Cardiolipin IgA ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — 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 IgG III ELISA Bulk Pack — INOVA DIAGNOSTICS, INC. · Class II
- RELISA® Cardiolipin IgG & IgM Antibody Test — IMMUNO CONCEPTS INC
- Autoimmune EIA — Bio-Rad Laboratories · Class II
- 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
K962469 also covers:
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
Sources (1)
- FDA UDI e784501f-17ce-4740-8206-a252551d091e 37 fields · synced Jun 8, 2026