Duns Number:354553091
Device Description: Mercodia Glucagon ELISA is an assay intended to measure the pancreatic hormone glucagon in Mercodia Glucagon ELISA is an assay intended to measure the pancreatic hormone glucagon inplasma and serum. Glucagon measurements are used in the diagnosis and treatment of patientswith various disorders of carbohydrate metabolism, including diabetes mellitus, hypoglycemia,and hyperglycemia.
Catalog Number
10-1271-01
Brand Name
Mercodia Glucagon ELISA
Version/Model Number
10-1271-01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JME
Product Code Name
Radioimmunoassay, Glucagon
Public Device Record Key
7d54af24-1578-4326-9e22-9966ef322536
Public Version Date
October 09, 2020
Public Version Number
1
DI Record Publish Date
October 01, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |