FDA.reportPublic FDA data

cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 System

Primary DI
00875197004885
Brand
cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 System
Company
Roche Diagnostics GmbH
Model
07000979190
Catalog number
07000979190
Published
2015-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
00875197004885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197004885008751970048858751970048850875197004885

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336217702Elecsys T309744975190097449751902026-09-04
07613336246672Elecsys Anti-HBc II09745009160097450091602026-09-04
07613336172827Elecsys DHEA-S II09043551190090435511902026-08-07
07613336172834Elecsys DHEA-S II09043560190090435601902026-08-07
07613336172841CalSet DHEA-S II09043586190090435861902026-08-07
07613336217696Elecsys Tg II09744967190097449671902026-08-07
07613336217764Elecsys Anti-Tg09745602190097456021902026-08-07
07613336223321Kidney KFRE Algorithm09891986001098919860012025-03-31
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884999050808Alinity mABBOTT MOLECULAR INC.MKT2023-08-30
00875197006414cobas® HBVRoche Molecular Systems, Inc.MKT2021-12-10
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
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