cobas omni Lysis Reagent LYS) 06997538190

GUDID 00875197004496

Roche Diagnostics GmbH

Nucleic acid extraction/isolation kit IVD
Primary Device ID00875197004496
NIH Device Record Key6bcb7606-bcd4-4196-a684-e4986d5b6680
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas omni Lysis Reagent LYS)
Version Model Number1.0
Catalog Number06997538190
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
GS100875197004496 [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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