Duns Number:080131636
Catalog Number
-
Brand Name
Mouse anti-MUC4 (1G8) Concentrate
Version/Model Number
182322
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 11, 2018
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
NJT
Product Code Name
IMMUNOHISTOCHEMISTRY REAGENTS AND KITS
Public Device Record Key
04afd9be-f723-4f10-9953-9dbc405cdf21
Public Version Date
December 11, 2018
Public Version Number
4
DI Record Publish Date
February 02, 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 | 634 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |
3 | A medical device with high risk that requires premarket approval | 12 |