Name: Microbiology device clearances: 95 FDA 510(k) decisions in the last 12 months
Creator: MentionFox

Decisions95

Applicants57

Latest2026-10-02

FDA decided 95 premarket notifications (510(k)s) for microbiology devices from 57 applicants in the last 12 months, newest first. Each row links to FDA's own record of the decision.

Decided	Applicant	Device	Where	Record
2026-10-02	Roche Diagnostics	Elecsys EBV EBNA IgG LSE	Indianapolis, Indiana	K260221
2026-10-02	Roche Diagnostics	Elecsys EBV VCA IgG LSE	Indianapolis, Indiana	K260232
2026-10-02	Roche Diagnostics	Elecsys EBV IgM LJN	Indianapolis, Indiana	K260233
2026-10-02	Cepheid®	Xpert Xpress CoV-2/Flu plus QOF	Sunnyvale, California	K263120
2026-10-01	bioMerieux, Inc.	VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) LON	Hazelwood, Missouri	K260283
2026-09-30	Centers for Disease Control and Prevention	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) OZE	Atlanta, Georgia	K263035
2026-09-28	Biomérieux, Inc.	VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) LON	Hazelwood, Missouri	K260619
2026-09-25	Cepheid	Xpert Respiratory Panel QOF	Sunnyvale, California	K261336
2026-09-24	QIAGEN GmbH	QIAstat-Dx BCID GN Plus AMR Panel PEN	DE	K262168
2026-09-23	Abbott Laboratories	Anti-HCV Next MZO	Abbott Park, Illinois	K262156
2026-09-22	Biofire Diagnostics	BIOFIRE Respiratory Panel 2.1 (RP2.1) QOF	Salt Lake City, Utah	K263054
2026-09-14	Becton Dickinson and Company	BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth JTZ	Sparks, Maryland	K262163
2026-09-11	Baebies, Inc.	FINDER Flu A&B/SARS-CoV-2 Test QOF	Durham, North Carolina	K261837
2026-09-04	Ortho Clinical Diagnostics Inc. (QuidelOrtho)	Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA PSZ	San Diego, California	K254262
2026-09-04	Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)	Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA QVF	San Diego, California	K254264
2026-08-31	Abbott Diagnostics Scarborough, Inc.	ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 OCC	Scarborough, Maine	K262747
2026-08-28	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) OZN	Pleasanton, California	K260045
2026-08-28	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) PGX	Pleasanton, California	K260047
2026-08-20	Hardy Diagnostics	HardyDisk AST Tebipenem 10µg (TBP10) JTN	Santa Maria, California	K262113
2026-08-07	Aptitude Medical Systems, Inc.	Metrix COVID Test; Metrix COVID Test Pro QWB	Goleta, California	K253453
2026-08-06	QIAGEN GmbH	QIAstat-Dx BCID GPF Plus AMR Panel PAM	DE	K254194
2026-07-24	Thermo Fisher Scientific (Oxoid Ltd.)	Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 JTN	GB	K261781
2026-07-23	Liofilchem, Inc.	Gepotidacin GEP 10 µg JTN	Waltham, Massachusetts	K261853
2026-07-17	Biofire Defense, LLC	BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit PMN	Salt Lake City, Utah	K261475
2026-07-16	Roche Molecular Systems, Inc.	cobas® BV/CV PQA	Pleasanton, California	K260021
2026-07-10	Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)	Sofia Lyme FIA; Sofia 2 Campylobacter FIA LSR	San Diego, California	K254295
2026-07-10	ACON Laboratories, Inc.	Flowflex Plus RSV + Flu A/B + COVID Rapid Test SCA	San Diego, California	K261212
2026-07-08	bioMerieux, Inc.	VITEK REVEAL GN AST Assay and VITEK REVEAL AST System SAN	Hazelwood, Missouri	K260160
2026-07-08	Roche Molecular Systems, Inc.	cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems QEP	Pleasanton, California	K260917
2026-07-02	Cepheid®	Xpert Carba-R POC	Sunnyvale, California	K261867
2026-06-26	Phast Corp.	PhAST instrument and PhAST Blood Culture Gram-negative Panel SAN	Boston, Massachusetts	K253316
2026-06-15	Diasorin Molecular, LLC	LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit PGX	Cypress, California	K260333
2026-06-12	Autonomous Medical Devices Incorporated	Fast PCR Mini Respiratory Panel QOF	Santa Ana, California	K252932
2026-06-10	DNA Genotek, Inc.	Colli-PeeDx Urine Collection Kit SIH	CA	K254121
2026-06-05	Assure Tech., LLC	Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test QYT	Wilmington, Delaware	K260754
2026-06-04	DiaSorin, Inc.	LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX LOM	Stillwater, Minnesota	K260770
2026-06-01	CorDx, Inc.	CorDx Tyfast COVID-19 Ag Rapid Test Rx QVF	Alpharetta, Georgia	K253882
2026-05-28	BD Diagnostic Systems	BD BACTEC FXI Culture System MDB	Sparks, Maryland	K260213
2026-05-27	Visby Medical, Inc.	Visby Medical Flu and COVID-19 Test SIA	San Jose, California	K253971
2026-05-19	Luminex Corporation	LIAISON PLEX Gastrointestinal Flex Assay PCH	Northbrook, Illinois	K253722
2026-05-19	Maine Molecular Quality Controls, Inc.	FilmArray TF Control Panel M527 PMN	Saco, Maine	K260577
2026-05-15	Roche Molecular Systems, Inc.	cobas liat CT/NG nucleic acid test QEP	Pleasanton, California	K253756
2026-05-15	Roche Molecular Systems, Inc.	cobas liat CT/NG/MG nucleic acid test QEP	Pleasanton, California	K253759
2026-05-11	Hardy Diagnostics	HardyDisk AST Gepotidacin 10µg (GEP10) JTN	Santa Maria, California	K260842
2026-05-01	Applied BioCode, Inc.	BioCode® Respiratory Pathogen Panel (RPP) OCC	Santa Fe Springs, California	K254139
2026-04-30	Hangzhou AllTest Biotech Co., Ltd.	AllTest Strep A Rapid Test GTY	CN	K260342
2026-04-28	Abbott Laboratories	Anti-HCV Next MZO	Abbott Park, Illinois	K252424
2026-04-21	bioMérieux SA	ETEST Gepotidacin (GEP) (0.016-256 µg/mL) JWY	FR	K260447
2026-04-17	Liofilchem s.r.l.	MTS Gepotidacin 0.016-256 µg/mL JWY	IT	K260696
2026-04-15	Q-Linea AB	ASTar BC G- Kit SAN	SE	K253573
2026-04-15	bioMerieux, Inc.	VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance LON	Hazelwood, Missouri	K260282
2026-04-13	Roche Diagnostics	Elecsys Anti-SARS-CoV-2 S QVP	Indianapolis, Indiana	K252280
2026-04-13	Healgen Scientific,, LLC	Heal-Check Rapid COVID-19 Antigen Self-Test QYT	Houston, Texas	K260095
2026-04-07	Roche Diagnostics	Elecsys Anti-HBc II SEI	Indianapolis, Indiana	K260046
2026-04-07	Roche Diagnostics	Elecsys Anti-HAV IgM LOL	Indianapolis, Illinois	K260048
2026-04-07	Roche Diagnostics	Elecsys Anti-HBc IgM SEI	Indianapolis, Indiana	K260049
2026-04-02	Becton, Dickinson and Company	Onclarity Self-Collection Kit SEP	Sparks, Maryland	K260184
2026-03-30	Baebies, Inc.	FINDER Flu A&B/SARS-CoV-2 Test QOF	Durham, North Carolina	K252269
2026-03-27	Streck, LLC	MDx-Chex for BCP PMN	La Vista, Nebraska	K260041
2026-03-26	BIOMERIEUX	VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) LON	Hazelwood, Missouri	K260281
2026-03-24	Lumos Diagnostics, Inc.	FebriDx Bacterial/Non-bacterial Assay QXA	Carlsbad, California	K260787
2026-03-23	Streck	MDx-Chex for BCN PMN	La Vista, Nebraska	K254166
2026-03-17	Streck, LLC	MDx-Chex for BCY PMN	La Vista, Nebraska	K254167
2026-03-13	Genbody.Inc.	GenBody COVID-19 Ag Home Test QYT	KR	K251916
2026-03-13	Beckman Coulter, Inc.	Access anti-HBc IgM SEI	Brea, California	K254059
2026-03-09	QIAGEN GmbH	QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B PCH	DE	K254032
2026-02-19	Beckman Coulter, Inc.	Access anti-HBc Total SEI	Chaska, Minnesota	K253687
2026-02-13	Lex Diagnostics Limited	VELO Respiratory Test QOF	GB	K251742
2026-01-30	Hangzhou Clongene Biotech Co., Ltd.	Clungene RSV Antigen Rapid Test GQG	CN	K253318
2026-01-27	Beckman Coulter, Inc.	Access anti-HAV IgM LOL	Chaska, Minnesota	K251995
2026-01-22	Copan Wasp Srl	PhenoMATRIX PPU	IT	K251511
2026-01-16	Cepheid	Xpert GI Panel PCH	Sunnyvale, California	K251721
2026-01-15	Nano-Ditech Corporation	Nano-Check Influenza A+B Test PSZ	Cranbury, New Jersey	K252283
2025-12-30	Techno-Path Manufacturing , Ltd.	Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) QCH	IE	K242492
2025-12-23	Diasorin Molecular, LLC	LIAISON NES FLU A/B, RSV & COVID-19 QOF	Cypress, California	K251978
2025-12-17	Roche Diagnostics	Elecsys Anti-SARS-CoV-2 QVP	Indianapolis, Indiana	K253839
2025-12-12	Ihealth Labs, Inc.	iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro SCA	Sunnyvale, California	K251085
2025-12-12	Ihealth Labs, Inc.	iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro SCA	Sunnyvale, California	K251092
2025-12-05	Thermo Fisher Scientific (Oxoid Ltd.)	Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 JTN	GB	K251337
2025-11-26	Medical Wire & Equipment Company (Bath), Ltd.	Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device JSM	GB	K242976
2025-11-26	ACON Laboratories, Inc.	Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip GTY	San Diego, California	K251697
2025-11-20	Roche Molecular Systems, Inc.	cobas liat Bordetella panel nucleic acid test OZZ	Pleasanton, California	K243753
2025-11-20	Hardy Diagnostics	HardyDisk AST Cefiderocol 30µg (FDC30) JTN	Santa Maria, California	K253105
2025-11-19	Cytovale, Inc.	IntelliSep Test QUT	South San Francisco, California	K250912
2025-11-17	Beckman Coulter, Inc.	Access Rubella IgG LFX	Chaska, Minnesota	K250588
2025-11-14	Princeton BioMeditech Corp.	Status COVID-19/Flu A&B SCA	Monmouth Junction, New Jersey	K251538
2025-11-14	Inanovate, Inc.	Lyme-ID IgG Test; Bio-ID800 LSR	Sioux Falls, South Dakota	K252627
2025-11-03	Roche Molecular Systems, Inc.	cobas CMV PAB	Pleasanton, California	K252481
2025-11-03	Roche Molecular Systems, Inc.	cobas HCV MZP	Pleasanton, California	K252484
2025-10-31	Becton, Dickinson and Company	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 PCI	Sparks, Maryland	K250358
2025-10-30	Diasorin Molecular, LLC	Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) QOF	Cypress, California	K252387
2025-10-27	Affinity Biosensors, LLC	LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system SAN	Santa Barbara, California	K251875
2025-10-22	Guangzhou Wondfo Biotech Co., Ltd.	WELLlife COVID-19 Antigen Test Rx QVF	CN	K251289
2025-10-22	ACON Laboratories, Inc.	Flowflex Plus RSV + Flu A/B + COVID Home Test SCA	San Diego, California	K251749
2025-10-22	QIAGEN GmbH	QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B PCH	DE	K252329

Where this comes from

Before most medical devices can be sold in the United States, the maker submits a premarket notification, a 510(k), and FDA decides whether the device is substantially equivalent to one already on the market. Every row here is one of those decisions, linked to FDA's own record of it. The product area is the medical specialty FDA files the device under; the location is the applicant's, as the submission gives it.

A clearance means the agency found the device substantially equivalent; it is not an endorsement. Where an applicant also files with the SEC under the same name in the same state, it links to that company's page.

All device clearances FDA warning letters

Cite this page

Permanent URL: https://mentionfox.com/fda/510k/microbiology

Last updated 2026-10-18

Microbiology device clearances: 95 FDA 510(k) decisions in the last 12 months. MentionFox, 2026-10-18. https://mentionfox.com/fda/510k/microbiology