CINtec p16 Histology 06695256001

GUDID 04015630984398

Ventana Medical Systems, Inc.

p16 antigen IVD, antibody p16 antigen IVD, antibody p16 antigen IVD, antibody p16 antigen IVD, antibody p16 antigen IVD, antibody p16 antigen IVD, antibody p16 antigen IVD, antibody p16 antigen IVD, antibody p16 antigen IVD, antibody p16 antigen IVD, antibody p16 antigen IVD, antibody p16 antigen IVD, antibody p16 antigen IVD, antibody p16 antigen IVD, antibody p16 antigen IVD, antibody p16 antigen IVD, antibody
Primary Device ID04015630984398
NIH Device Record Key17f71a31-1fc6-425c-8326-01da502be4a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCINtec p16 Histology
Version Model Number06695256001
Catalog Number06695256001
Company DUNS184042521
Company NameVentana Medical Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630984398 [Primary]

FDA Product Code

NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-11
Device Publish Date2021-02-03

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