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Microbiology FDA 510(k) clearances, last 90 days

US companies with an FDA 510(k) clearance in Microbiology from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.

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Last 90 days

27 clearances in the last 90 days. The same 90 days a year earlier: 23.

For contract manufacturers and test labs

Microbiology accounts for 27 US 510(k) clearances in the last 90 days. The product code with the most clearances in this window is QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents). Contract manufacturers and test labs that work on Microbiology devices can read the company, the device and the date below, then open the FDA record. Contacts for these companies come with a free month.

Top product codes

Product codeDevice typeClearances
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents6
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation2
LSEEpstein-Barr Virus, Other2
OCCRespiratory Virus Panel Nucleic Acid Assay System2
PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays2
27 clearances, Aug 2, 2026 to Oct 30, 2026.
Decision dateCompanyDeviceFDA record
Oct 30, 2026Maine Molecular Quality Controls, Inc.eplex RP3 Control M530; eplex RP3 NegativeK263232
Oct 30, 2026GenMark Diagnostics, Inc.cobas eplex respiratory pathogen panel 3K262938
Oct 27, 2026BD Diagnostic Solutions / Becton, Dickinson & CompanyBD Veritor System for SARS-CoV-2K261379
Oct 22, 2026CepheidXpert Xpress CoV-2/Flu plusK263333
Oct 21, 2026Maine Molecular Quality Controls, Inc.SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative ControlK262573
Oct 21, 2026Biofire Diagnostics, LLCBIOFIRE SPOTFIRE Vaginitis (VG) PanelK262136
Oct 21, 2026Nuclein, LLCDASH Flu A/B TestK261347
Oct 19, 2026Beckman Coulter, Inc.Access MeMed BVK261109
Oct 14, 2026CorDx, Inc.CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid TestK262432
Oct 2, 2026CepheidXpert Xpress CoV-2/Flu plusK263120
Oct 2, 2026Roche DiagnosticsElecsys EBV IgMK260233
Oct 2, 2026Roche DiagnosticsElecsys EBV VCA IgGK260232
Oct 2, 2026Roche DiagnosticsElecsys EBV EBNA IgGK260221
Oct 1, 2026bioMerieux, Inc.VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)K260283
Sep 28, 2026Biomérieux, Inc.VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)K260619
Sep 25, 2026CepheidXpert Respiratory PanelK261336
Sep 23, 2026Abbott LaboratoriesAnti-HCV NextK262156
Sep 22, 2026Biofire DiagnosticsBIOFIRE Respiratory Panel 2.1 (RP2.1)K263054
Sep 14, 2026Becton Dickinson and CompanyBD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton BrothK262163
Sep 11, 2026Baebies, Inc.FINDER Flu A&B/SARS-CoV-2 TestK261837
Sep 4, 2026Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAK254264
Sep 4, 2026Ortho Clinical Diagnostics Inc. (QuidelOrtho)Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAK254262
Aug 31, 2026Abbott Diagnostics Scarborough, Inc.ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0K262747
Aug 28, 2026Roche Molecular Systems, Inc.cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)K260047
Aug 28, 2026Roche Molecular Systems, Inc.cobas Cdiff Nucleic acid test for use on the cobas Liat System (07454945190); cobas Cdiff Positive and Negative Control Kit for use on the cobas Liat System (07454970190)K260045
  • Oct 30, 2026
    Maine Molecular Quality Controls, Inc.

    eplex RP3 Control M530; eplex RP3 Negative

    K263232
  • Oct 30, 2026
    GenMark Diagnostics, Inc.

    cobas eplex respiratory pathogen panel 3

    K262938
  • Oct 27, 2026
    BD Diagnostic Solutions / Becton, Dickinson & Company

    BD Veritor System for SARS-CoV-2

    K261379
  • Oct 22, 2026
    Cepheid

    Xpert Xpress CoV-2/Flu plus

    K263333
  • Oct 21, 2026
    Maine Molecular Quality Controls, Inc.

    SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control

    K262573
  • Oct 21, 2026
    Biofire Diagnostics, LLC

    BIOFIRE SPOTFIRE Vaginitis (VG) Panel

    K262136
  • Oct 21, 2026
    Nuclein, LLC

    DASH Flu A/B Test

    K261347
  • Oct 19, 2026
    Beckman Coulter, Inc.

    Access MeMed BV

    K261109
  • Oct 14, 2026
    CorDx, Inc.

    CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test

    K262432
  • Oct 2, 2026
    Cepheid

    Xpert Xpress CoV-2/Flu plus

    K263120
  • Oct 2, 2026
    Roche Diagnostics

    Elecsys EBV IgM

    K260233
  • Oct 2, 2026
    Roche Diagnostics

    Elecsys EBV VCA IgG

    K260232
  • Oct 2, 2026
    Roche Diagnostics

    Elecsys EBV EBNA IgG

    K260221
  • Oct 1, 2026
    bioMerieux, Inc.

    VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)

    K260283
  • Sep 28, 2026
    Biomérieux, Inc.

    VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)

    K260619
  • Sep 25, 2026
    Cepheid

    Xpert Respiratory Panel

    K261336
  • Sep 23, 2026
    Abbott Laboratories

    Anti-HCV Next

    K262156
  • Sep 22, 2026
    Biofire Diagnostics

    BIOFIRE Respiratory Panel 2.1 (RP2.1)

    K263054
  • Sep 14, 2026
    Becton Dickinson and Company

    BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth

    K262163
  • Sep 11, 2026
    Baebies, Inc.

    FINDER Flu A&B/SARS-CoV-2 Test

    K261837
  • Sep 4, 2026
    Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)

    Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA

    K254264
  • Sep 4, 2026
    Ortho Clinical Diagnostics Inc. (QuidelOrtho)

    Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA

    K254262
  • Aug 31, 2026
    Abbott Diagnostics Scarborough, Inc.

    ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0

    K262747
  • Aug 28, 2026
    Roche Molecular Systems, Inc.

    cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)

    K260047
  • Aug 28, 2026
    Roche Molecular Systems, Inc.

    cobas Cdiff Nucleic acid test for use on the cobas Liat System (07454945190); cobas Cdiff Positive and Negative Control Kit for use on the cobas Liat System (07454970190)

    K260045

Source: FDA public records. The K number is in Whimbrel's corpus, and the company, device, state, product code and review panel are the openFDA 510(k) fields for that K number. FDA data through October 30, 2026. Each K number links to the FDA record. openFDA data are not validated by the FDA for medical decisions. Check the FDA record before you rely on a row. openFDA 510(k) API. FDA 510(k) database.

FAQ

Is a 510(k) an FDA approval?
No. The FDA clears a device through a 510(k) when it finds the device substantially equivalent to one already sold in the US.
Where do these rows come from?
From openFDA's 510(k) records, for K numbers Whimbrel already holds. Each K number links to the FDA 510(k) database.
Why do some review panels have no page?
A review panel page is published when the last 90 days have 10 or more US clearances in that panel.

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