VENTANA MET (SP44) RxDx Assay 08866856001

GUDID 07613336168974

Ventana Medical Systems, Inc.

Hepatocyte growth factor receptor (HGFR) IVD, antibody
Primary Device ID07613336168974
NIH Device Record Key73072f75-4604-4c23-a734-6fdb8973916c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVENTANA MET (SP44) RxDx Assay
Version Model Number08866856001
Catalog Number08866856001
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 Producttrue
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
GS107613336168974 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

SERImmunohistochemistry Assay, Antibody, MET

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-30
Device Publish Date2025-06-20

Devices Manufactured by Ventana Medical Systems, Inc.

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