Identity
- Trade Name
- Insulin ELISA Kit (DAKO) FDA UDI
- Generic Name
- Insulin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Insulin ELISA Kit provides a method for the quantitative determination of human insulin in serum or plasma. As with all diagnostic tests, a definitve clinical diagnosis should not be based on the results of a single test, but should be made by the physician after all clinical findings have been evaluated. The analysis should be performed by trained laboratory professionals. FDA UDI
- Model / Reference
- K2379 FDA UDI
- Description
- Insulin ELISA Kit provides a method for the quantitative determination of human insulin in serum or plasma. As with all diagnostic tests, a definitve clinical diagnosis should not be based on the results of a single test, but should be made by the physician after all clinical findings have been evaluated. The analysis should be performed by trained laboratory professionals. FDA UDI
Identifiers
- Catalog Number
- K2379 FDA UDI
- Primary DI / UDI-DI
- 07350108630047 FDA UDI
- FDA Product Code
- CFP FDA UDI
- GMDN Term
- Insulin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1405 FDA UDI
- Commercial Distribution
- Not 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
Insulin ELISA Kit (DAKO) by Mercodia AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 489c44c9-8951-45fb-88e9-07aa1017cd1d 37 fields · synced May 30, 2026