Identity
- Trade Name
- Mercodia Lp(a) ELISA FDA UDI
- Generic Name
- Lipoprotein Lp(a) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Mercodia Lp(a) ELISA provides a method for the quantitative determination of human Lp(a) in serum or plasma. FDA UDI
- Model / Reference
- 10-1106-01 FDA UDI
- Description
- Mercodia Lp(a) ELISA provides a method for the quantitative determination of human Lp(a) in serum or plasma. FDA UDI
Identifiers
- Catalog Number
- 10-1106-01 FDA UDI
- Primary DI / UDI-DI
- 07350108630016 FDA UDI
- FDA Product Code
- MSJ FDA UDI
- GMDN Term
- Lipoprotein Lp(a) 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
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
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: Lipoprotein Lp(a) IVD, kit, enzyme immunoassay (EIA)
Mercodia Lp(a) ELISA is a highly sensitive and specific method for quantifying human Lp(a) in serum or plasma, widely used in the diagnosis and treatment of lipid disorders such as diabetes mellitus, atherosclerosis, and various liver and renal diseases.
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
- Mercodia AB
Sources (1)
- FDA UDI 98e9d6f4-5318-486e-89b0-d1110e7ab188 36 fields · synced Jul 21, 2026