OptiView DAB Detection Kit 06396500001

GUDID 04015630984039

Ventana Medical Systems, Inc.

Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry
Primary Device ID04015630984039
NIH Device Record Keyfbe70d56-8655-4b65-87b4-82fcd843d28a
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiView DAB Detection Kit
Version Model Number06396500001
Catalog Number06396500001
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630984039 [Primary]

FDA Product Code

NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-15
Device Publish Date2021-02-05

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