FDA.reportPublic FDA data

cobas® HBV

Primary DI
00875197006414
Brand
cobas® HBV
Company
Roche Molecular Systems, Inc.
Model
09040820190
Catalog number
09040820190
Published
2021-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MKTHepatitis Viral B DNA Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKTHepatitis Viral B Dna DetectionMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00875197006414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197006414008751970064148751970064140875197006414

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071674100
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00875197007480cobas BV/CV Control Kit09988807190099888071902026-09-28
00875197007497cobas BV/CV09988815190099888151902026-09-28
07613336175934Digital LightCycler Partitioning Engine09224777001092247770012026-09-24
07613336175941Digital LightCycler Analyzer09274804001092748040012026-09-24
07613336231098Opulus Lymphoma Precision10257873001102578730012026-05-08
00875197006476cobas® HBV/HCV/HIV-1 Control Kit09040773190090407731902021-12-10
00875197004014cobas® TaqScreen MPX Control Kit, v2.02.0059653901902015-02-20
00875197001068COBAS® AmpliScreen HCV Test, v2.02033025630182014-09-17
00875197001099COBAS® AmpliScreen HIV-1 Test, v1.52033221140182014-09-09
00875197001662cobas® TaqScreen MPX Test04584252190045842521902014-09-17
00875197002102COBAS® AmpliScreen HBV Test03599779190035997791902014-09-17
00875197004045cobas® TaqScreen MPX Test, v2.02.0059694841902015-02-20
07613336206355cobas® 6800 system09575154001095751540012026-03-26
07613336206362cobas® 8800 system09575146001095751460012026-03-26
00875197007459cobas® Liat Transfer Pipette Pack10383852190103838521902026-03-26
00875197005240cobas® Cdiff Test06768237190067682371902026-02-24
00875197005288cobas® 4800 Cdiff Controls and Cofactor Kit06768300190067683001902026-02-24
00875197006056cobas® TV/MG08017450190080174501902026-02-24
00875197006063cobas® TV/MG Positive Control Kit07948689190079486891902026-02-24
00875197006377cobas® SARS-CoV-2 & Influenza A/B Quality Control Kit09211128190092111281902026-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884999050808Alinity mABBOTT MOLECULAR INC.MKT2023-08-30
00884999047754Alinity mABBOTT MOLECULAR INC.MKT2020-09-23
00884999047808Alinity mABBOTT MOLECULAR INC.MKT2020-09-23
00884999047815Alinity mABBOTT MOLECULAR INC.MKT2020-09-23
00884999048645Alinity mABBOTT MOLECULAR INC.MKT2020-09-23
15420045506749Aptima®Hologic, Inc.MKT2018-01-30
15420045506756Aptima®Hologic, Inc.MKT2018-01-30
15420045506763Aptima®Hologic, Inc.MKT2018-01-30
15420045506770Aptima®Hologic, Inc.MKT2018-01-30
00884999042667RealTimeABBOTT MOLECULAR INC.MKT2016-07-28
00875197004717cobas® HIV1 Quantitative nucleic acid test for use on the cobas® 68 88 SystemsRoche Diagnostics GmbHMKT2016-02-26
00875197004885cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 SystemRoche Diagnostics GmbHMKT2015-12-04
00884999003057RealTimeABBOTT MOLECULAR INC.MKT2014-11-20
00884999003064RealTimeABBOTT MOLECULAR INC.MKT2014-11-20
00884999003071RealTimeABBOTT MOLECULAR INC.MKT2014-11-20
00884999037762RealTimeABBOTT MOLECULAR INC.MKT2014-11-20
00884999038462RealTimeABBOTT MOLECULAR INC.MKT2014-11-20
04015630936557DOCKING STATION SHORTRoche Molecular Systems, Inc.MKT2014-09-19
04038377020556High Pure System Viral Nucleic Acid KitRoche Molecular Systems, Inc.MKT2014-09-10
00875197002003COBAS® TaqMan® HBV Test, For Use With The High Pure SystemRoche Molecular Systems, Inc.MKT2014-09-10
00875197002034COBAS® AmpliPrep / COBAS® TaqMan® Wash ReagentRoche Molecular Systems, Inc.MKT2014-09-10
00875197002706COBAS® AmpliPrep / COBAS® TaqMan® HBV Test, v2.0Roche Molecular Systems, Inc.MKT2014-09-09