ultraView SISH DNP Detection Kit 05572037001

GUDID 04015630970384

Ventana Medical Systems, Inc.

Nucleic acid hybridization detection IVD, kit
Primary Device ID04015630970384
NIH Device Record Key4beb6bcb-6433-4ebc-bad6-bb4e9056969f
Commercial Distribution StatusIn Commercial Distribution
Brand NameultraView SISH DNP Detection Kit
Version Model Number100 tests
Catalog Number05572037001
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 Kittrue
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
GS104015630970384 [Primary]

FDA Product Code

PPMGeneral purpose reagent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2025-12-12
Device Publish Date2014-09-12

Devices Manufactured by Ventana Medical Systems, Inc.

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