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Data / Medical devices / United States / Roche Molecular Systems, Inc.

Roche Molecular Systems, Inc.: FDA-registered device maker in Pleasanton, CA, United States, 34 510(k) clearances and 13 PMA approvals

Roche Molecular Systems, Inc. is registered with the FDA (registration 3004141078) in Pleasanton, CA, United States. It lists 36 device types. The FDA files 34 510(k) clearances and 13 PMA approvals under its listings, the newest dated July 16, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Roche Molecular Systems, Inc.
FDA registration number
3004141078
Address
4300 Hacienda Drive, Pleasanton, CA, United States, 94588
Owner or operator
Roche Diagnostics Operations Inc. (9039767)
Roles
Manufacturer, Specification developer
First device listed
March 6, 2001
Registered through
2027
Brand names listed
A1CD, cobas c 503, AMPLILINK Software Version 3.4, AVENIO Edge System, Accelerator I 1 x 100ML, AcfS Detection Robot, AcfS L&D Equipment Installation Bundle, AcfS Library Robot, Acid Wash Solution and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Chemistry, Micro, For Clinical UseJJF1Specification developeraccessdata.fda.gov
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C VirusMZP2Manufacturer, Specification developeraccessdata.fda.gov
Automated Radiological Image Processing SoftwareQIH2Specification developeraccessdata.fda.gov
Bordetella Pertussis Dna Assay SystemOZZ2Specification developeraccessdata.fda.gov
C. Difficile Toxin Gene Amplification AssayOZN2Specification developeraccessdata.fda.gov
Clinical Sample ConcentratorJJH1Specification developeraccessdata.fda.gov
Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid DevicesQLTNSpecification developeraccessdata.fda.gov
Culture-Based Short-Term Incubation Antimicrobial Resistance AssayQIV2Specification developeraccessdata.fda.gov
Cytomegalovirus (Cmv) Dna Quantitative AssayPAB2Specification developeraccessdata.fda.gov
Dna Probe, Nucleic Acid Amplification, ChlamydiaMKZ1Specification developeraccessdata.fda.gov
Dna-Reagents, NeisseriaLSL2Specification developeraccessdata.fda.gov
General Purpose ReagentPPM1Specification developeraccessdata.fda.gov
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification SystemPGX2Specification developeraccessdata.fda.gov
Hepatitis Viral B Dna DetectionMKT2Specification developeraccessdata.fda.gov
Herpes Simplex Virus Nucleic Acid Amplification AssayOQO2Specification developeraccessdata.fda.gov
Human Immunodeficiency Virus (Hiv) Viral Load Monitoring TestQUM2Specification developeraccessdata.fda.gov
Influenza A And Influenza B Multiplex Nucleic Acid AssayOZE2Specification developeraccessdata.fda.gov
Instrumentation For Clinical Multiplex Test SystemsNSU2Specification developeraccessdata.fda.gov
Kit, Dna Detection, Human PapillomavirusMAQ3Specification developeraccessdata.fda.gov
Lab-Based Hiv Nat Diagnostic And/Or Supplemental TestQST2Specification developeraccessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsQOF2Specification developeraccessdata.fda.gov
Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) DnaQMI2Specification developeraccessdata.fda.gov
Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) DnaQLX2Specification developeraccessdata.fda.gov
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted InfectionsQEP2Specification developeraccessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic AcidQJRNSpecification developeraccessdata.fda.gov
Reagents, Monkeypox Virus Nucleic Acid.QTPNSpecification developeraccessdata.fda.gov
Real Time Nucleic Acid Amplification SystemOOI2Specification developeraccessdata.fda.gov
Respiratory Specimen Nucleic Acid Sars-Cov-2 TestQQX2Specification developeraccessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay SystemOCC2Specification developeraccessdata.fda.gov
Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient SettingsQWR2Specification developeraccessdata.fda.gov
Somatic Gene Mutation Detection SystemOWD3Specification developeraccessdata.fda.gov
Station, Pipetting And Diluting, For Clinical UseJQW1Specification developeraccessdata.fda.gov
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct SpecimenNQX2Specification developeraccessdata.fda.gov
Test, Equipment, Automated Bloodborne PathogenMZANSpecification developeraccessdata.fda.gov
Test, Hiv DetectionMZF2Specification developeraccessdata.fda.gov
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection SystemPQA2Specification developeraccessdata.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
July 16, 2026K260021cobas® BV/CVPQASubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
May 15, 2026K253759cobas liat CT/NG/MG nucleic acid testQEPSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
November 20, 2025K243753cobas liat Bordetella panel nucleic acid testOZZSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
July 31, 2025K243455cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 SystemsQOFSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
May 30, 2025K243863Opulus™ Lymphoma PrecisionQIHSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
April 25, 2025K243406cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid testQOFSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
April 25, 2025K243400cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid testQOFSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
April 11, 2025K243346cobas liat SARS-CoV-2 v2 nucleic acid testQWRSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
January 17, 2025K240217cobas® liat CT/NG nucleic acid testQEPSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
January 16, 2025K240197cobas® liat CT/NG/MG nucleic acid testQEPSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
December 4, 2023K223783cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemQWRSubstantially 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
November 4, 2022K221007cobas HCVMZPSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
October 22, 2022K213804cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 SystemsQQXSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
January 29, 2021K203220cobas BKVQLXSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.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
December 5, 2019DEN190016cobas vivoDx MRSAQIVUnknownRoche Molecular Systems, Inc.accessdata.fda.gov
May 22, 2019K190433cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control KitQEPSubstantially EquivalentRoche 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
February 9, 2017K163184cobas® CT/NG v2.0 TestLSLSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.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
May 5, 2014K140887COBAS CT/NG V2.0 TESTLSLSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
December 2, 2013K132270COBAS CT/NG V2.0 TESTLSLSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
January 24, 2012K110923COBAS 4800 CT / NG TESTMKZSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
August 4, 2011K111387LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZEROCCSubstantially EquivalentIquum, Inc.accessdata.fda.gov
July 6, 2010K091409LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727NQXSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
December 17, 2003K033734LIGHTCYCLER INSTRUMENT VERSION 1.2JJFSubstantially EquivalentRoche Diagnostics Corp.accessdata.fda.gov
February 1, 2002K012966ROCHE COBAS TAQMAN ANALYZERJJFSubstantially EquivalentRoche Molecular 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
April 3, 2020P190028cobas HPV for use on the cobas 6800/8800 SystemsMAQ25June 16, 2026accessdata.fda.gov
June 1, 2017P160041COBAS CMVPAB46October 10, 2024accessdata.fda.gov
June 1, 2016P150047cobas EGFR MUTATION TEST v2OWD2October 19, 2016accessdata.fda.gov
October 14, 2015P150015COBAS HCV TESTMZP42June 2, 2021accessdata.fda.gov
October 14, 2015P150014COBAS HBV TESTMKT57October 17, 2025accessdata.fda.gov
May 7, 2015P140023COBAS KRAS MUTATION TESTOWD32March 17, 2026accessdata.fda.gov
May 14, 2013P120019COBAS EGFR MUTATION TESTOWD41March 17, 2026accessdata.fda.gov
July 5, 2012P110037COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)PAB64October 4, 2024accessdata.fda.gov
August 17, 2011P110020COBAS 4800 BRAF V600 MUTATION TESTOWD44March 17, 2026accessdata.fda.gov
April 19, 2011P100020COBAS HPV TESTMAQ64March 17, 2026accessdata.fda.gov
October 30, 2008P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TESTMZP83August 11, 2021accessdata.fda.gov
September 4, 2008P050028COBAS TAQMAN HBV TESTMKT88October 4, 2024accessdata.fda.gov

Compare with other makers

Updated July 16, 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.