AccessGUDID - DEVICE: VENTANA ANTI-MLH1 (M1) Mouse Monoclonal Primary Antibody (07613336100561)

GUDID

Device Identifier (DI) Information

Brand Name: VENTANA ANTI-MLH1 (M1) Mouse Monoclonal Primary Antibody
Version or Model: 790-5091
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 07862237001
Company Name: Ventana Medical Systems, Inc.

Primary DI Number: 07613336100561
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184042521 *Terms of Use

Device Description: MMR IHC Panel Antibody

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59542	Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to evaluate a clinical specimen to diagnose, monitor or predict hereditary nonpolyposis colon cancer (HNPCC) associated with mutations in one of several genes that are important in the detection and repair ofdeoxyribonucleic acid (DNA) base-pair mismatches, which may include MLH1, MSH2, MLH3, MSH6, PMS1 and PMS2.	Active	false
63699	MLH1 protein IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of MLH1, a DNA mismatch repair protein, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QNH	Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
PZJ	Lynch Syndrome Test System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN170030	000
P200019	000
P210001	000
P210001	001

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a7ad46e9-36df-4f43-9557-72b8f52afe4a
Public Version Date: May 11, 2022
Public Version Number: 6
DI Record Publish Date: February 08, 2018