VENTANA Anti MSH2 (G219-1129) Mouse Monoclonal Pri

GUDID 07613336100585

For use with the MMR IHC Panel

Ventana Medical Systems, Inc.

Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
Primary Device ID07613336100585
NIH Device Record Key62c528c4-4b87-4010-a41b-b9168337af8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameVENTANA Anti MSH2 (G219-1129) Mouse Monoclonal Pri
Version Model Number790-5093
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
GS107613336100585 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PZJLynch Syndrome Test System
QNHImmunohistochemistry test, DNA mismatch repair (MMR) Protein assay

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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