Identity
- Trade Name
- Mercodia Glucagon ELISA FDA UDI
- Generic Name
- Glucagon IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Mercodia Glucagon ELISA is an assay intended to measure the pancreatic hormone glucagon in plasma and serum. Glucagon measurements are used in the diagnosis and treatment of patients with various disorders of carbohydrate metabolism, including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA UDI
- Model / Reference
- 10-1271-01 FDA UDI
- Description
- Mercodia Glucagon ELISA is an assay intended to measure the pancreatic hormone glucagon in plasma and serum. Glucagon measurements are used in the diagnosis and treatment of patients with various disorders of carbohydrate metabolism, including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA UDI
Identifiers
- Catalog Number
- 10-1271-01 FDA UDI
- Primary DI / UDI-DI
- 07350108630115 FDA UDI
- FDA Product Code
- JME FDA UDI
- GMDN Term
- Glucagon IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1335 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
Mercodia Glucagon ELISA 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 d56ba04e-b0e1-462b-a4f4-cad592b1f2b1 37 fields · synced May 30, 2026