VENTANA FOLR1 (FOLR1-2.1) RxDx Assay 07727917001

GUDID 07613336103241

Ventana Medical Systems, Inc.

Folate receptor alpha (FRa) IVD, antibody
Primary Device ID07613336103241
NIH Device Record Keydb3020ae-e09b-476e-afa8-3cfcdf64b555
Commercial Distribution StatusIn Commercial Distribution
Brand NameVENTANA FOLR1 (FOLR1-2.1) RxDx Assay
Version Model Number07727917001
Catalog Number07727917001
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
GS107613336103241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QULImmunohistochemistry Assay, Antibody, FOLR1

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-09
Device Publish Date2022-12-01

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