Duns Number:184042521
Device Description: For use the MMR IHC Panel
Catalog Number
07862261001
Brand Name
VENTANA Anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody
Version/Model Number
790-5094
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P210001,DEN170030,P200019,P210001
Product Code
PZJ
Product Code Name
Lynch Syndrome Test System
Public Device Record Key
afa222e8-08eb-405d-968b-14645549e953
Public Version Date
May 11, 2022
Public Version Number
5
DI Record Publish Date
February 08, 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 | 134 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |
| 3 | A medical device with high risk that requires premarket approval | 7 |