Duns Number:965326957
Catalog Number
K46009-010
Brand Name
ihcDirect® Mart-1 Ab Conjugate 10mL
Version/Model Number
H31009-R010
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
930fd0c4-ce39-46de-b39a-804885c8a02a
Public Version Date
August 30, 2021
Public Version Number
1
DI Record Publish Date
August 20, 2021
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 | 245 |