BenchMark GX 05894662001

GUDID 07613336140956

Ventana Medical Systems, Inc.

Microscope slide stainer IVD
Primary Device ID07613336140956
NIH Device Record Key08c4549e-0608-410d-8916-2e1c85413da7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBenchMark GX
Version Model Number05894662001
Catalog Number05894662001
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336140956 [Primary]

FDA Product Code

KPASlide stainer, automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-23
Device Publish Date2025-12-15

Devices Manufactured by Ventana Medical Systems, Inc.

04015630971008 - Antibody Diluent2025-12-23
04015630971176 - Bluing Reagent2025-12-23
04015630971299 - Amplification Kit2025-12-23
04015630971367 - Alcian Blue Staining Kit2025-12-23
04015630971374 - Alcian Blue for PAS2025-12-23
04015630971404 - Giemsa Staining Kit2025-12-23
04015630971411 - Iron Staining Kit2025-12-23
04015630971428 - Light Green for PAS2025-12-23

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