Mercodia Glucagon ELISA
FDA UDIEUDAMEDClass I (US FDA UDI)
by Mercodia AB
Identity
- Trade Name
- Mercodia Glucagon ELISA EUDAMEDFDA UDI
- Generic Name
- Glucagon IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Mercodia Glucagon ELISA EUDAMEDMercodia 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 EUDAMEDFDA 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
- 07350108630122 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07350108630122 EUDAMED
- FDA Product Code
- JME FDA UDI
- EMDN Code
- W0102060102 GLUCAGON EUDAMED
- GMDN Term
- Glucagon IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1335 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: Glucagon IVD, kit, enzyme immunoassay (EIA)
Mercodia Glucagon 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 7d54af24-1578-4326-9e22-9966ef322536 36 fields · synced Jul 10, 2026
- EUDAMED e0f27aa1-649e-4901-9c49-9f4832002dbc 61 fields · synced Jul 10, 2026