FDA.reportPublic FDA data

COBAS® TaqMan®

Primary DI
04015630925537
Brand
COBAS® TaqMan®
Company
Roche Molecular Systems, Inc.
Model
03121453001
Catalog number
03121453001
Published
2014-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JJFANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJFAnalyzer, Chemistry, Micro, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630925537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630925537040156309255374015630925537

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratory, automatedAn electrically-powered laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification, and operates with minimal technician input and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071674100
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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
00875197006742cobas SARS-CoV-209408592190094085921902026-02-24
00875197006759cobas SARS-CoV-2 Quality Control Kit09408835190094088351902026-02-24
00875197006902cobas® TV/MG09040633190090406331902026-02-24
00875197006919cobas® TV/MG Positive Control Kit09040641190090406411902026-02-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810039380512Cholestech LDX™Alere San Diego, Inc.JJF2023-12-20
05055273205893RX daytonaRANDOX LABORATORIES LIMITEDJJF2018-06-07
00854361008003Alere Cholestech LDX®Alere San Diego, Inc.JJF2018-03-30
03661540600180V-Twin®VitalScientific B.V.JJF2016-11-21
00725609000496SPOTCHECKASTORIA-PACIFIC, INC.JJF2016-10-14
00725609000502SPOTCHECKASTORIA-PACIFIC, INC.JJF2016-10-14
00817439020062Wash Concentrate 1Medtest Dx, Inc.JJF2016-09-27
00817439020079Wash Concentrate 2Medtest Dx, Inc.JJF2016-09-27
00817439020086Wash Concentrate 3Medtest Dx, Inc.JJF2016-09-27
00817439021373MedTest DX Wash Solution for the BS200Medtest Dx, Inc.JJF2016-09-27
05055273205091RABSRANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273205947WASH conc. 3RANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273205961ISE DIL URNRANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273206043WASH conc. 2RANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273206050WASH conc. 1RANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273206074Cl SOLNRANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273206111NSRANDOX LABORATORIES LIMITEDJJF2016-09-26
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05055273210361SOLN WASHRANDOX LABORATORIES LIMITEDJJF2016-09-26
08056771102148LIAISON® XLDIASORIN SPAJJF2016-09-24
00817273020464DiamedixDIAMEDIX CORPORATIONJJF2016-09-21
00817273020471DiamedixDIAMEDIX CORPORATIONJJF2016-09-21
04015630924691cobas 6000 core unitRoche Diagnostics GmbHJJF2016-09-20
04015630924707cobas c 501 ModuleRoche Diagnostics GmbHJJF2016-09-20
04015630925551cobas c 311Roche Diagnostics GmbHJJF2016-09-20
04015630924745COBAS®TaqMan® 48 AnalyzerRoche Molecular Systems, Inc.JJF2014-09-17