PIK3CA DNP Probe ASR 06621023001

GUDID 04015630970872

Ventana Medical Systems, Inc.

Assay development analyte-specific reagent IVD
Primary Device ID04015630970872
NIH Device Record Key02f7fce5-8d09-4d12-baa1-1be7f1619fe1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePIK3CA DNP Probe ASR
Version Model Number06621023001
Catalog Number06621023001
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 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630970872 [Primary]

FDA Product Code

MVUReagents, specific, analyte

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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