Chromosome 10 DIG Probe ASR 06577571001

GUDID 04015630970841

Ventana Medical Systems, Inc.

Assay development analyte-specific reagent IVD
Primary Device ID04015630970841
NIH Device Record Keyeb3f64a0-4c07-4072-9b51-0d4b86b4886c
Commercial Distribution StatusIn Commercial Distribution
Brand NameChromosome 10 DIG Probe ASR
Version Model Number06577571001
Catalog Number06577571001
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
GS104015630970841 [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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