BenchMark Ultra LCS 05424534001

GUDID 04015630972418

Ventana Medical Systems, Inc.

Buffered wash solution IVD
Primary Device ID04015630972418
NIH Device Record Keye07c1ef5-5d46-4b56-a9ad-f3f41b5e8f8d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBenchMark Ultra LCS
Version Model Number05424534001
Catalog Number05424534001
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630972418 [Primary]

FDA Product Code

PPMGeneral purpose reagent

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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