Duns Number:929504710
Device Description: Monoclonal Mouse Anti- Glypican-3, Clone 1G12
Catalog Number
-
Brand Name
Thermo Scientific
Version/Model Number
MS-1939-R7
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NJT
Product Code Name
Immunohistochemistry Reagents And Kits
Public Device Record Key
4df9d1b2-9b26-4ebc-adf4-24ecec97de29
Public Version Date
August 24, 2018
Public Version Number
2
DI Record Publish Date
June 12, 2018
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 | 906 |
2 | A medical device with a moderate to high risk that requires special controls. | 10 |