Duns Number:025048773
Device Description: Hepatocyte Specific Antigen (Hep Par-1) (OCH1E5) Mouse Monoclonal Antibody
Catalog Number
-
Brand Name
Hepatocyte Specific Antigen (Hep Par-1) (OCH1E5) Mouse Monoclonal Antibody
Version/Model Number
264M-96
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
f23c234d-2edb-4bd3-b8df-87f5f5d2c247
Public Version Date
August 31, 2020
Public Version Number
1
DI Record Publish Date
August 21, 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 | 984 |