Identity
- Trade Name
- Anti-Cardiolipin Screen ELISA FDA UDI
- Generic Name
- Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Anti-Cardiolipin Screen ELISA is a test system for the quantitative measurement of IgG, IgM and IgA class autoantibodies against cardiolipin in human serum or plasma. FDA UDI
- Model / Reference
- EIA-3589 FDA UDI
- Description
- Anti-Cardiolipin Screen ELISA is a test system for the quantitative measurement of IgG, IgM and IgA class autoantibodies against cardiolipin in human serum or plasma. FDA UDI
Identifiers
- Catalog Number
- EIA-3589 FDA UDI
- Primary DI / UDI-DI
- 04048474035896 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 Screen ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 1f1564fa-bda8-4ba6-b95b-93c520c03af7 37 fields · synced Jun 1, 2026