Identity
- Trade Name
- ox-LDL ELISA FDA UDI
- Generic Name
- Oxidized low density lipoprotein (OxLDL) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- K 7810.20.US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04050598010444 FDA UDI
- FDA Product Code
- LBS FDA UDI
- GMDN Term
- Oxidized low density lipoprotein (OxLDL) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Oxidized low density lipoprotein (OxLDL) IVD, kit, enzyme immunoassay (EIA)
ox-LDL ELISA by Immundiagnostik, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oxidized low density lipoprotein (OxLDL) IVD, kit, enzyme immunoassay (EIA).
- Mercodia Oxidized LDL ELISA — Mercodia AB · Class I
- ox-LDL ELISA — IMMUNDIAGNOSTIK, INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Immundiagnostik, Inc.
Sources (1)
- FDA UDI 917d5686-326e-4140-be4b-be7b35229a50 33 fields · synced May 30, 2026