FDA.reportPublic FDA data

cobas 6000 core unit

Primary DI
04015630924691
Brand
cobas 6000 core unit
Company
Roche Diagnostics GmbH
Model
4745868001
Catalog number
4745868001
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060373000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060373000COBAS 6000 SERIES SYSTEMRoche Diagnostics2006-03-13CEM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630924691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630924691040156309246914015630924691

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality clinical specimen analysis system IVDAn assembly of mains electricity (AC-powered) devices consisting of two or more analysers of different analytic modalities [e.g., immunoassay and photometric (clinical chemistry)] intended to be used for the qualitative and/or quantitative determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin, electrolytes) in a clinical specimen. The assembly may also include a sample preparation instrument, reagent management instrument, data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.

Regulatory Flags#

DUNS number
315028860
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
05055273206289SABSRANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273206982AWSRANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273210361SOLN WASHRANDOX LABORATORIES LIMITEDJJF2016-09-26
08056771102148LIAISON® XLDIASORIN SPAJJF2016-09-24
00817273020464DiamedixDIAMEDIX CORPORATIONJJF2016-09-21
00817273020471DiamedixDIAMEDIX CORPORATIONJJF2016-09-21
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
04015630925537COBAS® TaqMan®Roche Molecular Systems, Inc.JJF2014-09-15