PATHWAY Anti-c-KIT (9.7) Primary Antibody 05278317001

GUDID 04015630971916

Ventana Medical Systems, Inc.

CD117 (c-kit) cell marker IVD, antibody
Primary Device ID04015630971916
NIH Device Record Key36758834-f0dd-470e-b544-08c43ddbac5f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePATHWAY Anti-c-KIT (9.7) Primary Antibody
Version Model Number50 tests
Catalog Number05278317001
Company DUNS184042521
Company NameVentana Medical Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630971916 [Primary]

FDA Product Code

NKFImmunohistochemistry antibody assay, c-kit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2025-07-08
Device Publish Date2014-09-11

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