Mercodia Ultrasensitive C-peptide ELISA
FDA UDIEUDAMEDClass I (US FDA UDI)
by Mercodia AB
Identity
- Trade Name
- Mercodia Ultrasensitive C-peptide ELISA EUDAMEDFDA UDI
- Generic Name
- C-peptide IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Mercodia Ultrasensitive C-peptide ELISA EUDAMEDMercodia Ultrasensitive C-peptide ELISA provides a method for the quantitative determination of human C-peptide in serum, plasma or urine. FDA UDI
- Model / Reference
- 10-1141-01 EUDAMEDFDA UDI
- Description
- Mercodia Ultrasensitive C-peptide ELISA provides a method for the quantitative determination of human C-peptide in serum, plasma or urine. FDA UDI
Identifiers
- Catalog Number
- 10-1141-01 FDA UDI
- Primary DI / UDI-DI
- 07350108630092 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07350108630092 EUDAMED
- FDA Product Code
- JKD FDA UDI
- EMDN Code
- W0102060101 C-PEPTIDE EUDAMED
- GMDN Term
- C-peptide IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1135 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
No
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: C-peptide IVD, kit, enzyme immunoassay (EIA)
Mercodia Ultrasensitive C-peptide ELISA by Mercodia AB — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 66698b15-0b0a-4518-8b1e-7df5dba5c2fd 36 fields · synced Jul 20, 2026
- EUDAMED e67e9d0a-91ba-4173-b2d7-ee3c25ad07cc 61 fields · synced Jul 20, 2026