Duns Number:784143778
Device Description: The Glucagon RIA is a radioimmunoassay for the quantitative measurement of glucagon in hum The Glucagon RIA is a radioimmunoassay for the quantitative measurement of glucagon in human plasma.
Catalog Number
38-GLUHU-R100
Brand Name
Glucagon RIA
Version/Model Number
38-GLUHU-R100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
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
ca7d9ef6-5e33-413e-b11b-5ebac80478f7
Public Version Date
September 27, 2022
Public Version Number
1
DI Record Publish Date
June 02, 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 | 42 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |