Identity
- Trade Name
- RELISA® Cardiolipin Antibody Screening Test FDA UDI
- Generic Name
- Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- RELISA® Cardiolipin Antibody Screening Test System - 96 Tests FDA UDI
- Model / Reference
- 7096-01 FDA UDI
- Description
- RELISA® Cardiolipin Antibody Screening Test System - 96 Tests FDA UDI
Identifiers
- Catalog Number
- 7096-01 FDA UDI
- Primary DI / UDI-DI
- M7497096011 FDA UDI
- GMDN Term
- Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- 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
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
RELISA® Cardiolipin Antibody Screening Test by Immuno Concepts Inc — 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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immuno Concepts Inc
Sources (1)
- FDA UDI eefb58f5-5da7-48e7-b8be-ec3dd3ee175a 35 fields · synced Jun 1, 2026