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

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis B virus core nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis B virus core nucleic acid in a clinical specimen, using a nucleic acid technique (NAT).

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884999050808Alinity mABBOTT MOLECULAR INC.MKT2023-08-30
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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