cobas¿ HBVHCVHIV1 Control Kit 06998887190

GUDID 00875197004748

Roche Diagnostics GmbH

HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
Primary Device ID00875197004748
NIH Device Record Keyefc546ca-bb8a-4308-9819-28cc1981a504
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas¿ HBVHCVHIV1 Control Kit
Version Model Number1.0
Catalog Number06998887190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
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 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
GS100875197004748 [Primary]

FDA Product Code

MZPASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-12-04

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