Review Panel
Microbiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,955
- Product Codes (page)
- 48
- Latest Decision
- 2026-10-02
Clearances · page 1 of 70
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K260233 | Elecsys EBV IgM | Roche Diagnostics | LJN | Class I | 2026-10-02 |
| K263120 | Xpert Xpress CoV-2/Flu plus | Cepheid® | QOF | Class II | 2026-10-02 |
| K260221 | Elecsys EBV EBNA IgG | Roche Diagnostics | LSE | Class I | 2026-10-02 |
| K260232 | Elecsys EBV VCA IgG | Roche Diagnostics | LSE | Class I | 2026-10-02 |
| K260283 | VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) | bioMerieux, Inc. | LON | Class II | 2026-10-01 |
| K263035 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit) | Centers for Disease Control and Prevention | OZE | Class II | 2026-09-30 |
| K260619 | VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) | Biomérieux, Inc. | LON | Class II | 2026-09-28 |
| K261336 | Xpert Respiratory Panel | Cepheid | QOF | Class II | 2026-09-25 |
| K262168 | QIAstat-Dx BCID GN Plus AMR Panel | QIAGEN GmbH | PEN | Class II | 2026-09-24 |
| K262156 | Anti-HCV Next | Abbott Laboratories | MZO | Class II | 2026-09-23 |
| K263054 | BIOFIRE Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics | QOF | Class II | 2026-09-22 |
| K262163 | BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth | Becton Dickinson and Company | JTZ | Class II | 2026-09-14 |
| K261837 | FINDER Flu A&B/SARS-CoV-2 Test | Baebies, Inc. | QOF | Class II | 2026-09-11 |
| K254264 | Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | QVF | Class II | 2026-09-04 |
| K254262 | Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA | Ortho Clinical Diagnostics Inc. (QuidelOrtho) | PSZ | Class II | 2026-09-04 |
| K262747 | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. | OCC | Class II | 2026-08-31 |
| K260047 | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190) | Roche Molecular Systems, Inc. | PGX | Class II | 2026-08-28 |
| K260045 | 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) | Roche Molecular Systems, Inc. | OZN | Class II | 2026-08-28 |
| K262113 | HardyDisk AST Tebipenem 10µg (TBP10) | Hardy Diagnostics | JTN | Class II | 2026-08-20 |
| K253453 | Metrix COVID Test; Metrix COVID Test Pro | Aptitude Medical Systems, Inc. | QWB | Class II | 2026-08-07 |
| K254194 | QIAstat-Dx BCID GPF Plus AMR Panel | QIAGEN GmbH | PAM | Class II | 2026-08-06 |
| K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 | Thermo Fisher Scientific (Oxoid Ltd.) | JTN | Class II | 2026-07-24 |
| K261853 | Gepotidacin GEP 10 µg | Liofilchem, Inc. | JTN | Class II | 2026-07-23 |
| K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | Biofire Defense, LLC | PMN | Class II | 2026-07-17 |
| K260021 | cobas® BV/CV | Roche Molecular Systems, Inc. | PQA | Class II | 2026-07-16 |
| K261212 | Flowflex Plus RSV + Flu A/B + COVID Rapid Test | ACON Laboratories, Inc. | SCA | Class II | 2026-07-10 |
| K254295 | Sofia Lyme FIA; Sofia 2 Campylobacter FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | LSR | Class II | 2026-07-10 |
| K260917 | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems | Roche Molecular Systems, Inc. | QEP | Class II | 2026-07-08 |
| K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | bioMerieux, Inc. | SAN | Class II | 2026-07-08 |
| K261867 | Xpert Carba-R | Cepheid® | POC | Class II | 2026-07-02 |
| K253316 | PhAST instrument and PhAST Blood Culture Gram-negative Panel | Phast Corp. | SAN | Class II | 2026-06-26 |
| K260333 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | Diasorin Molecular, LLC | PGX | Class II | 2026-06-15 |
| K252932 | Fast PCR Mini Respiratory Panel | Autonomous Medical Devices Incorporated | QOF | Class II | 2026-06-12 |
| K254121 | Colli-PeeDx Urine Collection Kit | DNA Genotek, Inc. | SIH | Class II | 2026-06-10 |
| K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test | Assure Tech., LLC | QYT | Class II | 2026-06-05 |
| K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | DiaSorin, Inc. | LOM | Class II | 2026-06-04 |
| K253882 | CorDx Tyfast COVID-19 Ag Rapid Test Rx | CorDx, Inc. | QVF | Class II | 2026-06-01 |
| K260213 | BD BACTEC FXI Culture System | BD Diagnostic Systems | MDB | Class I | 2026-05-28 |
| K253971 | Visby Medical Flu and COVID-19 Test | Visby Medical, Inc. | SIA | Class II | 2026-05-27 |
| K260577 | FilmArray TF Control Panel M527 | Maine Molecular Quality Controls, Inc. | PMN | Class II | 2026-05-19 |
| K253722 | LIAISON PLEX Gastrointestinal Flex Assay | Luminex Corporation | PCH | Class II | 2026-05-19 |
| K253759 | cobas liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. | QEP | Class II | 2026-05-15 |
| K253756 | cobas liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. | QEP | Class II | 2026-05-15 |
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics | JTN | Class II | 2026-05-11 |
| K254139 | BioCode® Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. | OCC | Class II | 2026-05-01 |
| K260342 | AllTest Strep A Rapid Test | Hangzhou AllTest Biotech Co., Ltd. | GTY | Class I | 2026-04-30 |
| K252424 | Anti-HCV Next | Abbott Laboratories | MZO | Class II | 2026-04-28 |
| K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | bioMérieux SA | JWY | Class II | 2026-04-21 |
| K260696 | MTS Gepotidacin 0.016-256 µg/mL | Liofilchem s.r.l. | JWY | Class II | 2026-04-17 |
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | bioMerieux, Inc. | LON | Class II | 2026-04-15 |
| K253573 | ASTar BC G- Kit | Q-Linea AB | SAN | Class II | 2026-04-15 |
| K260095 | Heal-Check Rapid COVID-19 Antigen Self-Test | Healgen Scientific,, LLC | QYT | Class II | 2026-04-13 |
| K252280 | Elecsys Anti-SARS-CoV-2 S | Roche Diagnostics | QVP | Class II | 2026-04-13 |
| K260049 | Elecsys Anti-HBc IgM | Roche Diagnostics | SEI | Class II | 2026-04-07 |
| K260048 | Elecsys Anti-HAV IgM | Roche Diagnostics | LOL | Class II | 2026-04-07 |
| K260046 | Elecsys Anti-HBc II | Roche Diagnostics | SEI | Class II | 2026-04-07 |
| K260184 | Onclarity Self-Collection Kit | Becton, Dickinson and Company | SEP | Class II | 2026-04-02 |
| K252269 | FINDER Flu A&B/SARS-CoV-2 Test | Baebies, Inc. | QOF | Class II | 2026-03-30 |
| K260041 | MDx-Chex for BCP | Streck, LLC | PMN | Class II | 2026-03-27 |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | BIOMERIEUX | LON | Class II | 2026-03-26 |
| K260787 | FebriDx Bacterial/Non-bacterial Assay | Lumos Diagnostics, Inc. | QXA | Class II | 2026-03-24 |
| K254166 | MDx-Chex for BCN | Streck | PMN | Class II | 2026-03-23 |
| K254167 | MDx-Chex for BCY | Streck, LLC | PMN | Class II | 2026-03-17 |
| K251916 | GenBody COVID-19 Ag Home Test | Genbody.Inc. | QYT | Class II | 2026-03-13 |
| K254059 | Access anti-HBc IgM | Beckman Coulter, Inc. | SEI | Class II | 2026-03-13 |
| K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH | PCH | Class II | 2026-03-09 |
| K253687 | Access anti-HBc Total | Beckman Coulter, Inc. | SEI | Class II | 2026-02-19 |
| K251742 | VELO Respiratory Test | Lex Diagnostics Limited | QOF | Class II | 2026-02-13 |
| K253318 | Clungene RSV Antigen Rapid Test | Hangzhou Clongene Biotech Co., Ltd. | GQG | Class I | 2026-01-30 |
| K251995 | Access anti-HAV IgM | Beckman Coulter, Inc. | LOL | Class II | 2026-01-27 |
| K251511 | PhenoMATRIX | Copan Wasp Srl | PPU | Class II | 2026-01-22 |
| K251721 | Xpert GI Panel | Cepheid | PCH | Class II | 2026-01-16 |
| K252283 | Nano-Check Influenza A+B Test | Nano-Ditech Corporation | PSZ | Class II | 2026-01-15 |
| K242492 | Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) | Techno-Path Manufacturing , Ltd. | QCH | Class II | 2025-12-30 |
| K251978 | LIAISON NES FLU A/B, RSV & COVID-19 | Diasorin Molecular, LLC | QOF | Class II | 2025-12-23 |
| K253839 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | QVP | Class II | 2025-12-17 |
| K251085 | iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro | Ihealth Labs, Inc. | SCA | Class II | 2025-12-12 |
| K251092 | iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro | Ihealth Labs, Inc. | SCA | Class II | 2025-12-12 |
| K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 | Thermo Fisher Scientific (Oxoid Ltd.) | JTN | Class II | 2025-12-05 |
| K242976 | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device | Medical Wire & Equipment Company (Bath), Ltd. | JSM | Class I | 2025-11-26 |
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip | ACON Laboratories, Inc. | GTY | Class I | 2025-11-26 |
| K243753 | cobas liat Bordetella panel nucleic acid test | Roche Molecular Systems, Inc. | OZZ | Class II | 2025-11-20 |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | JTN | Class II | 2025-11-20 |
| K250912 | IntelliSep Test | Cytovale, Inc. | QUT | Class II | 2025-11-19 |
| K250588 | Access Rubella IgG | Beckman Coulter, Inc. | LFX | Class II | 2025-11-17 |
| K251538 | Status COVID-19/Flu A&B | Princeton BioMeditech Corp. | SCA | Class II | 2025-11-14 |
| K252627 | Lyme-ID IgG Test; Bio-ID800 | Inanovate, Inc. | LSR | Class II | 2025-11-14 |
| K252481 | cobas CMV | Roche Molecular Systems, Inc. | PAB | Class II | 2025-11-03 |
| K252484 | cobas HCV | Roche Molecular Systems, Inc. | MZP | Class II | 2025-11-03 |
| K250358 | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System | Becton, Dickinson and Company | PCI | Class II | 2025-10-31 |
| K252387 | Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) | Diasorin Molecular, LLC | QOF | Class II | 2025-10-30 |
| K251875 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors, LLC | SAN | Class II | 2025-10-27 |
| K251749 | Flowflex Plus RSV + Flu A/B + COVID Home Test | ACON Laboratories, Inc. | SCA | Class II | 2025-10-22 |
| K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH | PCH | Class II | 2025-10-22 |
| K251289 | WELLlife COVID-19 Antigen Test Rx | Guangzhou Wondfo Biotech Co., Ltd. | QVF | Class II | 2025-10-22 |
| K251595 | COVID-19 Detect Rapid Self -Test | InBios International, Inc. | QYT | Class II | 2025-10-12 |
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | Gold Standard Diagnostics, LLC | GMQ | Class II | 2025-10-10 |
| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | Liofilchem s.r.l. | JWY | Class II | 2025-10-02 |
| K251501 | Visby Medical Men's Sexual Health Test | Visby Medical, Inc. | QEP | Class II | 2025-10-01 |
| K250050 | miDiagnostics HSV-1&2 CSF Test | Midiagnostics NV | PGH | Class II | 2025-09-30 |
6,955 clearances in the Microbiology panel. Data: openFDA.