Identity
- Trade Name
- Anti-Cardiolipin-A ELISA FDA UDI
- Generic Name
- Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Anti-Cardiolipin-A ELISA is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human Beta-2-glycoprotein I (Beta-2-GPI) for the semiquantitative and qualitative detection of IgA antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and Beta-2-GPI which are only expressed when Beta-2-GPI interacts with cardiolipin. The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjunction with other serological tests and clinical findings. FDA UDI
- Model / Reference
- 35-CAAHU-E01 FDA UDI
- Description
- The Anti-Cardiolipin-A ELISA is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human Beta-2-glycoprotein I (Beta-2-GPI) for the semiquantitative and qualitative detection of IgA antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and Beta-2-GPI which are only expressed when Beta-2-GPI interacts with cardiolipin. The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjunction with other serological tests and clinical findings. FDA UDI
Identifiers
- Catalog Number
- 35-CAAHU-E01 FDA UDI
- Primary DI / UDI-DI
- B24235CAAHUE010 FDA UDI
- 510(k) Number
- K040463 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
- Not 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
No
FDA UDI
Anti-Cardiolipin-A ELISA by American Laboratory Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K040463 also covers:
- AESKULISA® Cardiolipin-A — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® Cardiolipin-A — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® Cardiolipin-Check — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® Cardiolipin-Check — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® Cardiolipin-GM — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® Cardiolipin-GM — Aesku.Diagnostics GmbH & Co. KG
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
- American Laboratory Products Company
Sources (1)
- FDA UDI b6ec934d-fbae-45cc-9f80-daeec2b66ec9 38 fields · synced Jun 8, 2026