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Data / Medical devices / Switzerland / Roche Diagnostics International Ltd.

Roche Diagnostics International Ltd.: FDA-registered device maker in ROTKREUZ Zug, Switzerland, 24 510(k) clearances and 6 PMA approvals

Roche Diagnostics International Ltd. is registered with the FDA (registration 3003795116) in ROTKREUZ Zug, Switzerland. It lists 158 device types. The FDA files 24 510(k) clearances and 6 PMA approvals under its listings, the newest dated January 16, 2025. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Roche Diagnostics International Ltd.
FDA registration number
3003795116
Address
Forrenstrasse 2, ROTKREUZ Zug, Switzerland, CH-6343
Owner or operator
Roche Diagnostics Operations Inc. (9039767)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed
March 6, 2001
Registered through
2027
Brand names listed
579-2-RSA Dynamic Interface v1.1, 713-2-cobase 8100 v1.5, 770-1-CCM-AOB v1.1, A1CD, cobas c 503, AMPLILINK Software Version 3.4, AST 1100Tests cobas c 701, AST/GOT 400T cobas c 111, ASTPM, 740Tests, cobas c 701 and more

Devices it lists

DeviceProduct codeClassRoleSource
Abnormal Hemoglobin QuantitationGKA2Manufactureraccessdata.fda.gov
Acid HematinGGF2Manufactureraccessdata.fda.gov
Acid Phosphatase, Disodium PhenylphosphateCJX2Manufactureraccessdata.fda.gov
Acid, Lactic, Enzymatic MethodKHP1Manufactureraccessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)KNK1Manufactureraccessdata.fda.gov
Agent, ClearingKEM1Manufactureraccessdata.fda.gov
Albumin, Antigen, Antiserum, ControlDCF2Manufactureraccessdata.fda.gov
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme MethodDIC2Manufactureraccessdata.fda.gov
Alkaline Picrate, Colorimetry, CreatinineCGX2Manufactureraccessdata.fda.gov
Alpha-1-Antitrypsin, Antigen, Antiserum, ControlDEM2Manufactureraccessdata.fda.gov
Alpha-1-Lipoprotein, Antigen, Antiserum, ControlDER2Manufactureraccessdata.fda.gov
Amikacin Serum AssayKLP2Manufactureraccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Manufacturer, Specification developeraccessdata.fda.gov
Analyzer, Chemistry, Micro, For Clinical UseJJF1Manufactureraccessdata.fda.gov
Assay, CarboxyhemoglobinGHS2Manufactureraccessdata.fda.gov
Assay, Glycosylated HemoglobinLCP2Manufactureraccessdata.fda.gov
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C VirusMZP2Manufactureraccessdata.fda.gov
Assay, Porphyrin, Spectrophotometry, LithiumNDW2Manufactureraccessdata.fda.gov
Automated Urinalysis SystemKQO1Manufactureraccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Manufactureraccessdata.fda.gov
Biuret (Colorimetric), Total ProteinCEK2Manufactureraccessdata.fda.gov
Blood, Occult, Colorimetric, In UrineJIO2Manufactureraccessdata.fda.gov
Bromcresol Green Dye-Binding, AlbuminCIX2Manufactureraccessdata.fda.gov
Bromcresol Purple Dye-Binding, AlbuminCJW2Manufactureraccessdata.fda.gov
C. Difficile Toxin Gene Amplification AssayOZN2Manufactureraccessdata.fda.gov
Calculator/Data Processing Module, For Clinical UseJQP1Manufacturer, Specification developeraccessdata.fda.gov
Calibrator, Multi-Analyte MixtureJIX2Manufactureraccessdata.fda.gov
Calibrators, Drug MixtureDKB2Manufactureraccessdata.fda.gov
Calibrators, Drug SpecificDLJ2Manufactureraccessdata.fda.gov
Cardiac C-Reactive Protein, Antigen, Antiserum, And ControlNQD2Manufactureraccessdata.fda.gov
Catalytic Methods, AmylaseJFJ2Manufactureraccessdata.fda.gov
Clinical Sample ConcentratorJJH1Manufactureraccessdata.fda.gov
Colorimetry, AcetaminophenLDP2Manufactureraccessdata.fda.gov
Colorimetry, CholinesteraseDIH1Manufactureraccessdata.fda.gov
Colorimetry, SalicylateDKJ2Manufactureraccessdata.fda.gov
Complement C3, Antigen, Antiserum, ControlCZW2Manufactureraccessdata.fda.gov
Complement C4, Antigen, Antiserum, ControlDBI2Manufactureraccessdata.fda.gov
Cresolphthalein Complexone, CalciumCIC2Manufactureraccessdata.fda.gov
Cytomegalovirus (Cmv) Dna Quantitative AssayPAB2Manufactureraccessdata.fda.gov
Data Acquisition SoftwarePQQ2Manufacturer, Specification developeraccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Manufactureraccessdata.fda.gov
Diazo Colorimetry, BilirubinCIG2Manufactureraccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Manufactureraccessdata.fda.gov
Differential Rate Kinetic Method, Cpk Or IsoenzymesJHS2Manufactureraccessdata.fda.gov
Dna Probe, Nucleic Acid Amplification, ChlamydiaMKZ1Exporter to the US, Manufactureraccessdata.fda.gov
Dna-Reagents, NeisseriaLSL2Exporter to the US, Manufactureraccessdata.fda.gov
Drug Mixture Control MaterialsDIF1Manufactureraccessdata.fda.gov
Drug Specific Control MaterialsLAS1Manufactureraccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Manufactureraccessdata.fda.gov
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhCHL2Manufactureraccessdata.fda.gov
Electrode, Ion Specific, CalciumJFP2Manufactureraccessdata.fda.gov
Electrode, Ion Specific, PotassiumCEM2Manufactureraccessdata.fda.gov
Electrode, Ion Specific, SodiumJGS2Manufacturer, Specification developeraccessdata.fda.gov
Electrode, Ion Specific, Urea NitrogenCDS2Manufactureraccessdata.fda.gov
Electrode, Ion-Specific, ChlorideCGZ2Manufactureraccessdata.fda.gov
Enzymatic Esterase--Oxidase, CholesterolCHH1Manufactureraccessdata.fda.gov
Enzymatic Method, AmmoniaJIF1Manufactureraccessdata.fda.gov
Enzymatic, Carbon-DioxideKHS2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, CocaineJXO2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, DigoxinKXT2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, DiphenylhydantoinDIP2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Manufacturer, Specification developeraccessdata.fda.gov
Enzyme Immunoassay, N-AcetylprocainamideLAN2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total ThyroxineKLI2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUManufactureraccessdata.fda.gov
Enzyme Immunoassay, PhenobarbitalDLZ2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, ProcainamideLAR2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, PropoxypheneJXN2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, QuinidineLBZ2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, TheophyllineKLS2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, Valproic AcidLEG2Manufactureraccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Manufacturer, Specification developeraccessdata.fda.gov
Ferritin, Antigen, Antiserum, ControlDBF2Manufactureraccessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding CapacityJMO1Manufactureraccessdata.fda.gov
Fibrin Split ProductsGHH2Manufactureraccessdata.fda.gov
Flame Photometry, LithiumJIH2Manufactureraccessdata.fda.gov
Fluorescence Polarization Immunoassay, CarbamazepineLGI2Manufactureraccessdata.fda.gov
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)MOJ2Manufactureraccessdata.fda.gov
Fluorescence Polarization Immunoassay, PhenobarbitalLGQ2Manufactureraccessdata.fda.gov
Fluorescence Polarization Immunoassay, TheophyllineLGS2Manufactureraccessdata.fda.gov
General Purpose ReagentPPM1Manufactureraccessdata.fda.gov
Glucose Oxidase, GlucoseCGA2Manufactureraccessdata.fda.gov
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification SystemPGX2Manufactureraccessdata.fda.gov
Haptoglobin, Antigen, Antiserum, ControlDAD2Manufactureraccessdata.fda.gov
Hepatitis Viral B Dna DetectionMKT2Manufactureraccessdata.fda.gov
Herpes Simplex Virus Nucleic Acid Amplification AssayOQO2Manufactureraccessdata.fda.gov
Hexokinase, GlucoseCFR2Manufacturer, Specification developeraccessdata.fda.gov
Iga, Antigen, Antiserum, ControlCZP2Manufactureraccessdata.fda.gov
Igg, Antigen, Antiserum, ControlDEW2Manufactureraccessdata.fda.gov
Igm (Mu Chain Specific), Antigen, Antiserum, ControlDAO2Manufactureraccessdata.fda.gov
Immunochemical, CeruloplasminCHN2Manufactureraccessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)JIR1Manufactureraccessdata.fda.gov
Influenza A And Influenza B Multiplex Nucleic Acid AssayOZE2Manufactureraccessdata.fda.gov
Instrument, Hematocrit, AutomatedGKF2Manufactureraccessdata.fda.gov
Instrumentation For Clinical Multiplex Test SystemsNSU2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Kinetic Method, Gamma-Glutamyl TranspeptidaseJQB1Manufactureraccessdata.fda.gov
Kit, Dna Detection, Human PapillomavirusMAQ3Manufactureraccessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, HdlLBS1Manufactureraccessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, TriglyceridesCDT1Manufactureraccessdata.fda.gov
Lipoprotein X, Antigen, Antiserum, ControlDEL1Manufactureraccessdata.fda.gov
Lipoprotein, Low-Density, Antigen, Antiserum, ControlDFC2Manufactureraccessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)JIL2Manufactureraccessdata.fda.gov
Method, Nephelometric, Immunoglobulins (G, A, M)CFN2Manufactureraccessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)JJY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsQOF2Manufactureraccessdata.fda.gov
Mycophenolic Acid Test SystemOAV2Manufactureraccessdata.fda.gov
Myoglobin, Antigen, Antiserum, ControlDDR2Manufactureraccessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate DehydrogenaseCFJ2Manufactureraccessdata.fda.gov
Nad-Nadh, Specific Reagent For Alcohol Enzyme MethodDML2Manufactureraccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/SgptCKA1Manufactureraccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/SgotCIT2Manufactureraccessdata.fda.gov
NephelometerJZW1Manufactureraccessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or IsoenzymesCJE2Manufactureraccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Manufactureraccessdata.fda.gov
Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) DnaQMI2Manufactureraccessdata.fda.gov
Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) DnaQLX2Manufactureraccessdata.fda.gov
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted InfectionsQEP2Manufactureraccessdata.fda.gov
Olive Oil Emulsion (Turbidimetric), LipaseCET1Manufactureraccessdata.fda.gov
Oximeter To Measure HemoglobinGLY2Manufactureraccessdata.fda.gov
OxyhemoglobinGGZ2Manufactureraccessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic PhosphorusCEO1Manufactureraccessdata.fda.gov
Photometric Method, Iron (Non-Heme)JIY1Manufactureraccessdata.fda.gov
Photometric Method, MagnesiumJGJ1Manufactureraccessdata.fda.gov
Radioassay, Triiodothyronine UptakeKHQ2Manufactureraccessdata.fda.gov
Radioimmunoassay, Lsd (125-I)DLB2Manufactureraccessdata.fda.gov
Radioimmunoassay, MethaqualoneKXS2Manufactureraccessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating HormoneJLW2Manufacturer, Specification developeraccessdata.fda.gov
Radioimmunoassay, TobramycinKLB2Manufactureraccessdata.fda.gov
Radioimmunoassay, VancomycinLEH2Manufactureraccessdata.fda.gov
Reagent, Coronavirus SerologicalQKONManufactureraccessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic AcidQJRNManufactureraccessdata.fda.gov
Real Time Nucleic Acid Amplification SystemOOI2Exporter to the US, Manufactureraccessdata.fda.gov
Refractometer For Clinical UseJRE1Manufactureraccessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay SystemOCC2Manufactureraccessdata.fda.gov
Somatic Gene Mutation Detection SystemOWD3Manufactureraccessdata.fda.gov
Station, Pipetting And Diluting, For Clinical UseJQW1Manufacturer, Specification developeraccessdata.fda.gov
System, Hemoglobin, AutomatedGKR2Manufactureraccessdata.fda.gov
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct SpecimenNQX2Manufactureraccessdata.fda.gov
System, Test, Beta-2-Microglobulin ImmunologicalJZG2Manufactureraccessdata.fda.gov
System, Test, C-Reactive ProteinDCN2Manufactureraccessdata.fda.gov
System, Test, Low Density, LipoproteinMRR1Manufactureraccessdata.fda.gov
System, Test, Rheumatoid FactorDHR2Manufactureraccessdata.fda.gov
System, Test, Urinary Methylmalonic AcidLPT2Manufactureraccessdata.fda.gov
Test, Cystatin CNDY2Manufactureraccessdata.fda.gov
Test, Equipment, Automated Bloodborne PathogenMZANManufactureraccessdata.fda.gov
Test, Hiv DetectionMZF2Manufactureraccessdata.fda.gov
Test, Urine LeukocyteLJX1Manufactureraccessdata.fda.gov
Transferrin, Antigen, Antiserum, ControlDDG2Manufactureraccessdata.fda.gov
Turbidimetric Method, LipoproteinsJHN1Manufactureraccessdata.fda.gov
Turbidimetric, Total ProteinJGQ2Manufactureraccessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea NitrogenCDQ2Manufactureraccessdata.fda.gov
Whole Blood Hemoglobin DeterminationKHG2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 16, 2025K240197cobas® liat CT/NG/MG nucleic acid testQEPSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
July 27, 2023K223591cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® SystemQOFSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
September 16, 2022K220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHCFRSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
September 2, 2020K202215cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitQMISubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
July 30, 2020DEN200015cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitQLXUnknownRoche Molecular Systems, Inc.accessdata.fda.gov
March 21, 2018K173887cobas CT/NG for use on cobas 6800/8800 systemsLSLSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
September 12, 2017K171770cobas Cdiff Nucleic acid test for use on the cobas Liat SystemOZNSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
January 23, 2017K162606Elecsys TSH assay, cobas e 801 Immunoassay analyzerJLWSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
July 25, 2016K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemOCCSubstantially EquivalentIquum, Inc.accessdata.fda.gov
June 1, 2015K150617cobas HSV 1 and 2 TestOQOSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
May 20, 2015K142422cobas Cdiff TestOZNSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
December 17, 2014K142721cobas MRSA/SA TestNQXSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
November 4, 2014K141338LIAT STREP A ASSAYPGXSubstantially EquivalentIquum, Inc.accessdata.fda.gov
December 2, 2013K132270COBAS CT/NG V2.0 TESTLSLSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
May 14, 2012K111188COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS BCHLSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
August 4, 2011K111387LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZEROCCSubstantially EquivalentIquum, Inc.accessdata.fda.gov
September 9, 2010K100853COBAS 8000 MODULAR SERIES ANALYZERDCFSubstantially EquivalentRoche Diagnostics Corp.accessdata.fda.gov
April 2, 2010K093555COBAS U411 TEST SYSTEMKQOSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
July 30, 2007K071211COBAS C 111 ANALYZERCITSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
October 17, 2003K032311ROCHE DIAGNOSTICS OMNI S ANALYZERCEMSubstantially EquivalentRoche Diagnostics Corp.accessdata.fda.gov
August 28, 2003K032453ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROLJJYSubstantially EquivalentBionostics, Inc.accessdata.fda.gov
February 1, 2002K012966ROCHE COBAS TAQMAN ANALYZERJJFSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
June 12, 1996K961458AVL 9180 ELECTROLYTE ANALYZERJFPSubstantially EquivalentAvl Scientific Corp.accessdata.fda.gov
September 8, 1995K951595ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTESCGXSubstantially EquivalentRoche Diagnostic Systems, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
June 18, 2020P200014cobas® EZH2 Mutation TestOWD10March 17, 2026accessdata.fda.gov
June 1, 2017P160041COBAS CMVPAB46October 10, 2024accessdata.fda.gov
October 14, 2015P150015COBAS HCV TESTMZP42June 2, 2021accessdata.fda.gov
October 14, 2015P150014COBAS HBV TESTMKT57October 17, 2025accessdata.fda.gov
April 19, 2011P100020COBAS HPV TESTMAQ64March 17, 2026accessdata.fda.gov
July 3, 2001P000012COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0MZP51August 4, 2016accessdata.fda.gov

Compare with other makers

Updated March 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.