VIRTUOSO System for IHC

GUDID 04015630985043

VENTANA MEDICAL SYSTEMS, INC.

Histology/cytology image-analysis software IVD
Primary Device ID04015630985043
NIH Device Record Key77a41492-83c0-4262-80fa-6f8dfb4e6cfd
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIRTUOSO System for IHC
Version Model Numberv5
Company DUNS078501720
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630985043 [Primary]

FDA Product Code

NQNMicroscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-27
Device Publish Date2016-09-24

Devices Manufactured by VENTANA MEDICAL SYSTEMS, INC.

04015630985043 - VIRTUOSO System for IHC2019-11-27
04015630985043 - VIRTUOSO System for IHC2019-11-27
07613336100608 - VENTANA Anti-BRAF V600E (VE1) Mouse Monoclonal Pri2018-07-06 To be used with MMR IHC Panel
07613336100592 - VENTANA Anti-PMS2 (A16-4) Mouse Monoclonal Primary2018-07-06 For use the MMR IHC Panel
07613336100585 - VENTANA Anti MSH2 (G219-1129) Mouse Monoclonal Pri2018-07-06 For use with the MMR IHC Panel
07613336100578 - VENTANA Anti MSH6 (SP93) Rabbit Monoclonal Primar2018-07-06 For use with MMR IHC Panel
07613336100561 - VENTANA ANTI-MLH1 (M1) Mouse Monoclonal Primary An2018-07-06 MMR IHC Panel Antibody

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