Duns Number:025048773
Catalog Number
-
Brand Name
Treponema pallidum Rabbit Polyclonal Antibody
Version/Model Number
397A-18
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 07, 2020
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
cbb4db1c-c882-40b7-8380-2180ce4544c5
Public Version Date
October 06, 2021
Public Version Number
2
DI Record Publish Date
December 07, 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 |