ISH iVIEW BLUE PLUS DETECTION KIT 05266181001

GUDID 04015630972029

Ventana Medical Systems, Inc.

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Primary Device ID04015630972029
NIH Device Record Key183a80ff-4201-45ff-86e0-437c1f218089
Commercial Distribution StatusIn Commercial Distribution
Brand NameISH iVIEW BLUE PLUS DETECTION KIT
Version Model Number05266181001
Catalog Number05266181001
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
GS104015630972029 [Primary]

FDA Product Code

PPMGeneral purpose reagent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-11
Device Publish Date2021-02-03

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