HybReady Solution 05917557001

GUDID 04015630971060

Ventana Medical Systems, Inc.

Nucleic acid hybridization detection IVD, reagent
Primary Device ID04015630971060
NIH Device Record Key8b07099a-6830-4657-aa1a-19f3782eeb23
Commercial Distribution StatusIn Commercial Distribution
Brand NameHybReady Solution
Version Model Number05917557001
Catalog Number05917557001
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
GS104015630971060 [Primary]

FDA Product Code

PPMGeneral purpose reagent

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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