Mercodia Oxidized LDL ELISA
FDA UDIEUDAMEDClass I (US FDA UDI)
by Mercodia AB
Identity
- Trade Name
- Mercodia Oxidized LDL ELISA EUDAMEDFDA UDI
- Generic Name
- Oxidized low density lipoprotein (OxLDL) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Mercodia Oxidized LDL ELISA EUDAMEDThe Mercodia Oxidized LDL ELISA kit is intended to be used for the in vitro quantitative measurement of oxidized low density lipoproteins (oxidized LDL) in human serum or plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. FDA UDI
- Model / Reference
- 10-1143-01 EUDAMEDFDA UDI
- Description
- The Mercodia Oxidized LDL ELISA kit is intended to be used for the in vitro quantitative measurement of oxidized low density lipoproteins (oxidized LDL) in human serum or plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. FDA UDI
Identifiers
- Catalog Number
- 10-1143-01 FDA UDI
- Primary DI / UDI-DI
- 07350108630139 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07350108630139 EUDAMED
- FDA Product Code
- MRR FDA UDI
- EMDN Code
- W0102010403 APOLIPOPROTEIN B EUDAMED
- GMDN Term
- Oxidized low density lipoprotein (OxLDL) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1475 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
Yes
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Oxidized low density lipoprotein (OxLDL) IVD, kit, enzyme immunoassay (EIA)
Mercodia Oxidized LDL ELISA by Mercodia AB — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Oxidized low density lipoprotein (OxLDL) IVD, kit, enzyme immunoassay (EIA).
- ox-LDL ELISA — IMMUNDIAGNOSTIK, INC. · Class I
- ox-LDL ELISA — IMMUNDIAGNOSTIK, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mercodia AB
Sources (2)
- FDA UDI abcf8d97-daa3-41cc-979c-85389fc317ea 36 fields · synced Jul 28, 2026
- EUDAMED 4a47d80d-32de-49fc-b8a1-231378619920 61 fields · synced Jul 28, 2026