ASSY RGT DSPNR CARD BMK PREP KIT 571 09840532001

GUDID 07613336221426

Ventana Medical Systems, Inc.

Assay container IVD, single-use
Primary Device ID07613336221426
NIH Device Record Key86463556-ad65-49b1-86b0-1a4531ed2e13
Commercial Distribution StatusIn Commercial Distribution
Brand NameASSY RGT DSPNR CARD BMK PREP KIT 571
Version Model Number09840532001
Catalog Number09840532001
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 Numbertrue
Manufacturing Datefalse
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
GS107613336221426 [Primary]

FDA Product Code

JRCMICRO PIPETTE

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

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04015630971411 - Iron Staining Kit2025-12-23
04015630971428 - Light Green for PAS2025-12-23

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