FDA.reportPublic FDA data

cobas c 501 Module

Primary DI
04015630924707
Brand
cobas c 501 Module
Company
Roche Diagnostics GmbH
Model
4745914001
Catalog number
4745914001
Published
2016-09-20
Public version status
Update
Distribution status
Not 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
04015630924707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630924707040156309247074015630924707

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, laboratory, automatedAn electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or more technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

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
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07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
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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
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810039380307Cholestech LDX™Alere San Diego, Inc.JJF2023-12-20
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
05055273206289SABSRANDOX LABORATORIES LIMITEDJJF2016-09-26
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05055273210361SOLN WASHRANDOX LABORATORIES LIMITEDJJF2016-09-26
08056771102148LIAISON® XLDIASORIN SPAJJF2016-09-24
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00817273020471DiamedixDIAMEDIX CORPORATIONJJF2016-09-21
04015630924691cobas 6000 core unitRoche Diagnostics GmbHJJF2016-09-20
04015630925551cobas c 311Roche Diagnostics GmbHJJF2016-09-20
04015630924745COBAS®TaqMan® 48 AnalyzerRoche Molecular Systems, Inc.JJF2014-09-17
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