cobas CTNG Positive Control Kit 07460082190

GUDID 00875197005783

Roche Molecular Systems, Inc.

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Primary Device ID00875197005783
NIH Device Record Keyc290e2fe-7a12-4dfc-82e2-16ecdd359fb0
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas CTNG Positive Control Kit
Version Model Number07460082190
Catalog Number07460082190
Company DUNS071674100
Company NameRoche Molecular Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
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
GS100875197005783 [Primary]

FDA Product Code

OOIreal time Nucleic acid amplification system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-05-28
Device Publish Date2018-04-26

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