VENTANA HER2 Dual ISH DNA Probe Cocktail 08314365001

GUDID 07613336158432

Ventana Medical Systems, Inc.

Nucleic acid hybridization detection IVD, probe
Primary Device ID07613336158432
NIH Device Record Key877db5c3-c2a6-483b-8fbd-4af78b3f1e78
Commercial Distribution StatusIn Commercial Distribution
Brand NameVENTANA HER2 Dual ISH DNA Probe Cocktail
Version Model Number08314365001
Catalog Number08314365001
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
GS107613336158432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NYQChromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-19
Device Publish Date2021-04-09

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