BenchMark ULTRA 05342716001

GUDID 04015630981052

Ventana Medical Systems, Inc.

Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry
Primary Device ID04015630981052
NIH Device Record Keyc9f4f1bf-bd77-4f9c-a766-6a25daac2751
Commercial Distribution StatusIn Commercial Distribution
Brand NameBenchMark ULTRA
Version Model Number110v
Catalog Number05342716001
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
GS104015630981052 [Primary]

FDA Product Code

KPASLIDE STAINER, AUTOMATED

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2025-12-12
Device Publish Date2014-09-19

Devices Manufactured by Ventana Medical Systems, Inc.

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04015630972173 - ultraView Universal DAB Detection Kit2025-12-12
04015630972289 - PATHWAY HER-2 4 in 1 Control Slides2025-12-12
04015630981052 - BenchMark ULTRA2025-12-12
04015630981052 - BenchMark ULTRA2025-12-12
07613336233764 - CONFIRM anti-MART-1/melan A (A103) Mouse Monoclonal Primary Antibody2025-09-12
07613336234426 - VENTANA anti-p63 (4A4) Mouse Monoclonal Primary Antibody2025-09-12 250 Tests
04015630972197 - PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody2025-09-08
04015630971114 - LCS (Predilute)2025-07-15

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