ASSY,Reag.Disp.Card,PrepKit 71,BenchMark 05253900001

GUDID 07613336125885

Ventana Medical Systems, Inc.

Assay container IVD, single-use
Primary Device ID07613336125885
NIH Device Record Keyc9e5118b-10a7-436d-91e6-de80937997cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameASSY,Reag.Disp.Card,PrepKit 71,BenchMark
Version Model Number05253900001
Catalog Number05253900001
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
GS107613336125885 [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 Date2025-07-15
Device Publish Date2025-07-07

On-Brand Devices [ASSY,Reag.Disp.Card,PrepKit 71,BenchMark]

0761333612744505252105001
0761333612588505253900001

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