VENTANA Anti-BRAF V600E (VE1) Mouse Monoclonal Pri 790-5095

GUDID 07613336100608

To be used with MMR IHC Panel

Ventana Medical Systems, Inc.

Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
Primary Device ID07613336100608
NIH Device Record Keyfb93473f-5994-406f-bf84-4facc48289be
Commercial Distribution StatusIn Commercial Distribution
Brand NameVENTANA Anti-BRAF V600E (VE1) Mouse Monoclonal Pri
Version Model Number790-5095
Catalog Number790-5095
Company DUNS184042521
Company NameVentana Medical Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336100608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PZJLynch Syndrome Test System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-02-08

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