NexES Dispenser Card Counterstain 1 05271720001

GUDID 07613336101179

Ventana Medical Systems, Inc.

Assay container IVD, single-use
Primary Device ID07613336101179
NIH Device Record Keyf3c28e9a-6db2-4faa-a02f-3d406c24a176
Commercial Distribution StatusIn Commercial Distribution
Brand NameNexES Dispenser Card Counterstain 1
Version Model Number05271720001
Catalog Number05271720001
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
GS107613336101179 [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

Devices Manufactured by Ventana Medical Systems, Inc.

04015630971114 - LCS (Predilute)2025-07-15
04015630976867 - ASSY,Reag.Disp.Card,PrepKit 18,BenchMark2025-07-15
04015630984299 - CINtec p16 Histology (50) CE2025-07-15
07613336100981 - ASSY,Reag.Disp.Card,PrepKit 13,BenchMark2025-07-15
07613336100998 - ASSY,Reag.Disp.Card,PrepKit 14,BenchMark2025-07-15
07613336101001 - ASSY,Reag.Disp.Card,PrepKit 4,BenchMark2025-07-15
07613336101018 - ASSY,Reag.Disp.Card,PrepKit 100,BenchMar2025-07-15
07613336101179 - NexES Dispenser Card Counterstain 12025-07-15
07613336101179 - NexES Dispenser Card Counterstain 12025-07-15

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