cobas¿ HBV Quantitative nucleic acid test for use on the cobas¿ 68008800 System 07000979190

GUDID 00875197004885

Roche Diagnostics GmbH

Hepatitis B virus core nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00875197004885
NIH Device Record Key98efb26a-312b-41e7-8a82-3266ee79cd1e
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas¿ HBV Quantitative nucleic acid test for use on the cobas¿ 68008800 System
Version Model Number7000979190
Catalog Number07000979190
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 Usetrue
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
GS100875197004885 [Primary]

FDA Product Code

MKTHepatitis Viral B DNA Detection

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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