Mercodia Insulin ELISA 10 pack
FDA UDIEUDAMEDClass I (US FDA UDI)
by Mercodia AB
Identity
- Trade Name
- Mercodia Insulin ELISA EUDAMEDFDA UDIMercodia Insulin ELISA – 10 pack EUDAMEDMercodia Insulin ELISA 10 pack FDA UDI
- Generic Name
- Insulin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Mercodia Insulin ELISA – 10 pack EUDAMEDMercodia Insulin ELISA EUDAMEDMercodia Insulin ELISA provides a method for the quantitative determination of human insulin in serum or plasma. FDA UDI
- Model / Reference
- 10-1113-10 EUDAMEDFDA UDI10-1113-01 EUDAMEDFDA UDIMercodia Insulin ELISA EUDAMED
- Description
- Mercodia Insulin ELISA provides a method for the quantitative determination of human insulin in serum or plasma. FDA UDI
Identifiers
- Catalog Number
- 10-1113-10 FDA UDI10-1113-01 FDA UDI
- Primary DI / UDI-DI
- 07350108630030 EUDAMEDFDA UDI07350108630023 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07350108630030 EUDAMEDB-07350108630023 EUDAMED
- FDA Product Code
- CFP FDA UDI
- EMDN Code
- W0102060103 INSULIN EUDAMED
- GMDN Term
- Insulin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1405 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: Insulin IVD, kit, enzyme immunoassay (EIA)
Mercodia Insulin ELISA 10 pack 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 (4)
- FDA UDI 18c2c112-024f-4f32-aaf0-b0488f6faf96 36 fields · synced Jul 27, 2026
- FDA UDI 380ab346-acee-4290-8a87-84095d1eaf80 36 fields · synced May 30, 2026
- EUDAMED 959a765f-4b44-46d8-be71-4eae11ab003c 61 fields · synced Jul 19, 2026
- EUDAMED 0cdf1e45-8479-46a0-90c2-51f48fa85fb9 61 fields · synced Jul 27, 2026