BenchMark Special Stains Stainer Module 06468373001

GUDID 04015630984510

Ventana Medical Systems, Inc.

Nucleic acid hybridization detection IVD, reagent
Primary Device ID04015630984510
NIH Device Record Key8280bea3-d6a2-42c4-a422-6a74e07b0bcf
Commercial Distribution StatusIn Commercial Distribution
Brand NameBenchMark Special Stains Stainer Module
Version Model Number06468373001
Catalog Number06468373001
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
GS104015630984510 [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.

07613336240281 - ASSY RGT DSPNR CARD BMK PREP KIT 3012026-03-30
07613336240298 - ASSY RGT DSPNR CARD BMK PREP KIT 3022026-03-30
07613336240304 - ASSY RGT DSPNR CARD BMK PREP KIT 3032026-03-30
07613336240311 - ASSY RGT DSPNR CARD BMK PREP KIT 3042026-03-30
07613336240328 - ASSY RGT DSPNR CARD BMK PREP KIT 3052026-03-30
07613336240335 - ASSY RGT DSPNR CARD BMK PREP KIT 3062026-03-30
07613336240342 - ASSY RGT DSPNR CARD BMK PREP KIT 3072026-03-30
07613336240359 - ASSY RGT DSPNR CARD BMK PREP KIT 3082026-03-30

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.