Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat Mercodia AB makes
Mercodia AB produces in vitro diagnostic (IVD) enzyme immunoassay (EIA) kits and controls for measuring insulin, C-peptide, glucagon, oxidized low-density lipoprotein (OxLDL), and lipoprotein Lp(a). Their products include ELISA-based assays for diabetes-related analytes, such as insulin and C-peptide, as well as controls for insulin synthesis pathway verification. The portfolio also covers specialized tests for cardiovascular risk markers like OxLDL and Lp(a).
These diagnostic devices are classified as Class I under regulatory frameworks, with listings maintained in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable IVD regulations for these analytical tools.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Mercodia AB manufacture?
Mercodia AB specializes in in vitro diagnostic (IVD) enzyme immunoassay (EIA) kits and controls. Their products focus on measuring key biomarkers related to diabetes and cardiovascular health, including insulin, C-peptide, glucagon, oxidized low-density lipoprotein (OxLDL), and lipoprotein Lp(a). These assays are designed for clinical laboratories to support diagnostic and monitoring needs.
Where is Mercodia AB based, and does that affect its regulatory compliance?
Mercodia AB operates from the United States, where its devices must comply with U.S. regulatory requirements for in vitro diagnostics. Since their products are classified as Class I devices, they are subject to general controls under FDA regulations, ensuring safety and performance without requiring additional pre-market approvals beyond standard registration and listing.
Which regulatory registries list Mercodia AB’s devices?
Mercodia AB’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, allowing them to verify the identity and regulatory status of the company’s Class I IVD kits and controls. The UDI system is a key resource for tracking authorized diagnostic products.
How are Mercodia AB’s devices classified under regulatory frameworks?
Mercodia AB’s devices fall under the Class I regulatory classification, which applies to low-risk in vitro diagnostics like enzyme immunoassay kits and controls. This classification means they are subject to general controls (e.g., proper labeling, manufacturing practices) but do not require pre-market approval or additional scrutiny beyond standard compliance measures. The classification reflects their minimal risk profile for patient safety.
What kinds of assays and controls does Mercodia AB offer for diabetes management?
Mercodia AB provides enzyme-linked immunosorbent assay (ELISA) kits and controls for critical diabetes-related analytes, including insulin, C-peptide, and glucagon. Their portfolio includes ultrasensitive assays (e.g., ultrasensitive insulin ELISA) for precise measurements, as well as controls like the *Diabetes Antigen Control* to verify assay performance. These tools help clinicians monitor diabetes progression and treatment efficacy by quantifying key metabolic markers.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- mercodia.com
- —
- —
- [email protected]
- Phone
- +4618570070
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 354553091
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mercodia C-peptide ELISA | 10-1136-01 | EUDAMEDFDA UDI | Class I | Active |
| Mercodia Ultrasensitive C-peptide ELISA | 10-1141-01 | EUDAMEDFDA UDI | Class I | Active |
| Mercodia Oxidized LDL ELISA | 10-1143-01 | FDA UDI | Class I | Unknown |
| Mercodia Ultrasensitive Insulin ELISA | 10-1132-01 | EUDAMEDFDA UDI | Class I | Active |
| Mercodia Lp(a) ELISA | 10-1106-01 | FDA UDI | Class I | Active |
| Diabetes Antigen Control (Unassayed) | 10-1134-01 | FDA UDI | Class I | Active |
| Mercodia Oxidized LDL ELISA | 10-1143-01 | EUDAMEDFDA UDI | Class I | Active |
| Mercodia Glucagon ELISA | 10-1271-01 | FDA UDI | Class I | Unknown |
| Mercodia Glucagon ELISA | 10-1271-01 | EUDAMEDFDA UDI | Class I | Active |
| Insulin ELISA Kit (DAKO) | K2379 | FDA UDI | Class I | Unknown |
| Mercodia Iso-Insulin ELISA | 10-1128-01 | FDA UDI | Class I | Active |
| Mercodia Insulin ELISA 10 pack | 10-1113-10 | EUDAMEDFDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.