VENTANA PD-L1 (SP263) Assay 07208162001

GUDID 04015630972784

Ventana Medical Systems, Inc.

Programmed death-ligand 1 (PD-L1) IVD, antibody
Primary Device ID04015630972784
NIH Device Record Keydd70dc67-19c7-4989-a5b8-1606a046d44a
Commercial Distribution StatusIn Commercial Distribution
Brand NameVENTANA PD-L1 (SP263) Assay
Version Model Number50 test
Catalog Number07208162001
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 Datetrue
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
GS104015630972784 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLSImmunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-11-08
Device Publish Date2017-09-26

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