VENTANA HE 600 Differentiating Solution 06544339001

GUDID 04015630974764

Ventana Medical Systems, Inc.

Kappa/lambda light chain messenger RNA IVD, probe
Primary Device ID04015630974764
NIH Device Record Key9a94d14f-cb20-4bc4-baf3-6a97c44c2a66
Commercial Distribution StatusIn Commercial Distribution
Brand NameVENTANA HE 600 Differentiating Solution
Version Model Number06544339001
Catalog Number06544339001
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
GS104015630974764 [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 Date2021-02-15
Device Publish Date2021-02-05

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