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
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2022
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
d56ba04e-b0e1-462b-a4f4-cad592b1f2b1
Public Version Date
September 30, 2022
Public Version Number
3
DI Record Publish Date
April 08, 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 |