ASSY RGT DSPNR CARD BMK PREP KIT 566 09840486001

GUDID 07613336221372

Ventana Medical Systems, Inc.

Assay container IVD, single-use
Primary Device ID07613336221372
NIH Device Record Keyb64d687b-c45c-4647-a8dc-f011ac6ed481
Commercial Distribution StatusIn Commercial Distribution
Brand NameASSY RGT DSPNR CARD BMK PREP KIT 566
Version Model Number09840486001
Catalog Number09840486001
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
GS107613336221372 [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

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.