Duns Number:184042521
Device Description: To be used with MMR IHC Panel
Catalog Number
07862270001
Brand Name
VENTANA Anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody
Version/Model Number
790-5095
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
DEN170030
Product Code
PZJ
Product Code Name
Lynch Syndrome Test System
Public Device Record Key
fb93473f-5994-406f-bf84-4facc48289be
Public Version Date
October 22, 2021
Public Version Number
4
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 |