Duns Number:458777323
Device Description: Glucagon - RIA
Catalog Number
-
Brand Name
Glucagon - RIA
Version/Model Number
RB310
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
c1c3c827-be37-48e1-beb0-a87c4b1bed6a
Public Version Date
January 17, 2020
Public Version Number
1
DI Record Publish Date
January 09, 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 | 30 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |