Duns Number:144968104
Device Description: Magnesium Arsenazo Bulk Liquid (Carolina)
Catalog Number
MAG2A-BUL
Brand Name
JAS Diagnostics, inc
Version/Model Number
MAG2A-BUL
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
-
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
JGJ
Product Code Name
Photometric Method, Magnesium
Public Device Record Key
9232676a-2ada-466a-91e0-6df8185f7f1b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 10, 2017
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 | 85 |
2 | A medical device with a moderate to high risk that requires special controls. | 163 |