Identity
- Trade Name
- ELISA Cardiolipin IgG/IgM/IgA Test System FDA UDI
- Generic Name
- Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ZEUS ELISA Cardiolipin IgG/IgM/IgA Test System is intended for the in vitro, qualitative measurement of IgG, IgM and/or IgA antibodies directed to Cardiolipin in human serum to aid in the diagnosis of primary antiphospholipid syndrome (PAPS) and secondary antiphospholipid syndrome (SAPS) in conjunction with other laboratory and clinical findings. FDA UDI
- Model / Reference
- 2Z51051 FDA UDI
- Description
- The ZEUS ELISA Cardiolipin IgG/IgM/IgA Test System is intended for the in vitro, qualitative measurement of IgG, IgM and/or IgA antibodies directed to Cardiolipin in human serum to aid in the diagnosis of primary antiphospholipid syndrome (PAPS) and secondary antiphospholipid syndrome (SAPS) in conjunction with other laboratory and clinical findings. FDA UDI
Identifiers
- Catalog Number
- 2Z51051 FDA UDI
- Primary DI / UDI-DI
- 00845533000345 FDA UDI
- GMDN Term
- Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- 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
No
FDA UDI
Category: Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
ELISA Cardiolipin IgG/IgM/IgA Test System by Zeus Scientific, Inc. — 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
- Anti-Cardiolipin IgA ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- 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
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA UDI c82e061d-98db-45a6-b06e-f55837144503 35 fields · synced May 30, 2026