VENTANA ANTI-MLH1 (M1) Mouse Monoclonal Primary An

GUDID 07613336100561

MMR IHC Panel Antibody

Ventana Medical Systems, Inc.

Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
Primary Device ID07613336100561
NIH Device Record Keya7ad46e9-36df-4f43-9557-72b8f52afe4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameVENTANA ANTI-MLH1 (M1) Mouse Monoclonal Primary An
Version Model Number790-5091
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
GS107613336100561 [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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