| Metrix COVID Test; Metrix COVID Test Pro (K253453) | Aptitude Medical Systems, Inc. | 2026-08-07 |
| QIAstat-Dx BCID GPF Plus AMR Panel (K254194) | QIAGEN GmbH | 2026-08-06 |
| Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 (K261781) | Thermo Fisher Scientific (Oxoid Ltd.) | 2026-07-24 |
| Gepotidacin GEP 10 µg (K261853) | Liofilchem, Inc. | 2026-07-23 |
| BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit (K261475) | Biofire Defense, LLC | 2026-07-17 |
| cobas® BV/CV (K260021) | Roche Molecular Systems, Inc. | 2026-07-16 |
| Flowflex Plus RSV + Flu A/B + COVID Rapid Test (K261212) | ACON Laboratories, Inc. | 2026-07-10 |
| Sofia Lyme FIA; Sofia 2 Campylobacter FIA (K254295) | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 2026-07-10 |
| cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems (K260917) | Roche Molecular Systems, Inc. | 2026-07-08 |
| VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (K260160) | bioMerieux, Inc. | 2026-07-08 |
| Xpert Carba-R (K261867) | Cepheid® | 2026-07-02 |
| PhAST instrument and PhAST Blood Culture Gram-negative Panel (K253316) | Phast Corp. | 2026-06-26 |
| LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit (K260333) | Diasorin Molecular, LLC | 2026-06-15 |
| Fast PCR Mini Respiratory Panel (K252932) | Autonomous Medical Devices Incorporated | 2026-06-12 |
| Colli-Pee•Dx Urine Collection Kit (K254121) | DNA Genotek, Inc. | 2026-06-10 |
| Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test (K260754) | Assure Tech., LLC | 2026-06-05 |
| LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX (K260770) | DiaSorin, Inc. | 2026-06-04 |
| CorDx Tyfast COVID-19 Ag Rapid Test Rx (K253882) | CorDx, Inc. | 2026-06-01 |
| BD BACTEC FXI Culture System (K260213) | BD Diagnostic Systems | 2026-05-28 |
| Visby Medical Flu and COVID-19 Test (K253971) | Visby Medical, Inc. | 2026-05-27 |
| LIAISON PLEX Gastrointestinal Flex Assay (K253722) | Luminex Corporation | 2026-05-19 |
| FilmArray TF Control Panel M527 (K260577) | Maine Molecular Quality Controls, Inc. | 2026-05-19 |
| cobas liat CT/NG/MG nucleic acid test (K253759) | Roche Molecular Systems, Inc. | 2026-05-15 |
| cobas liat CT/NG nucleic acid test (K253756) | Roche Molecular Systems, Inc. | 2026-05-15 |
| HardyDisk AST Gepotidacin 10µg (GEP10) (K260842) | Hardy Diagnostics | 2026-05-11 |
| BioCode® Respiratory Pathogen Panel (RPP) (K254139) | Applied BioCode, Inc. | 2026-05-01 |
| AllTest Strep A Rapid Test (K260342) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-30 |
| Anti-HCV Next (K252424) | Abbott Laboratories | 2026-04-28 |
| ETEST Gepotidacin (GEP) (0.016-256 µg/mL) (K260447) | bioMérieux SA | 2026-04-21 |
| MTS Gepotidacin 0.016-256 µg/mL (K260696) | Liofilchem s.r.l. | 2026-04-17 |
| VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (K260282) | bioMerieux, Inc. | 2026-04-15 |
| ASTar BC G- Kit (K253573) | Q-Linea AB | 2026-04-15 |
| Elecsys Anti-SARS-CoV-2 S (K252280) | Roche Diagnostics | 2026-04-13 |
| Heal-Check Rapid COVID-19 Antigen Self-Test (K260095) | Healgen Scientific,, LLC | 2026-04-13 |
| Elecsys Anti-HBc IgM (K260049) | Roche Diagnostics | 2026-04-07 |
| Elecsys Anti-HBc II (K260046) | Roche Diagnostics | 2026-04-07 |
| Elecsys Anti-HAV IgM (K260048) | Roche Diagnostics | 2026-04-07 |
| Onclarity™ Self-Collection Kit (K260184) | Becton, Dickinson and Company | 2026-04-02 |
| FINDER Flu A&B/SARS-CoV-2 Test (K252269) | Baebies, Inc. | 2026-03-30 |
| MDx-Chex for BCP (K260041) | Streck, LLC | 2026-03-27 |
| VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (K260281) | BIOMERIEUX | 2026-03-26 |
| FebriDx Bacterial/Non-bacterial Assay (K260787) | Lumos Diagnostics, Inc. | 2026-03-24 |
| MDx-Chex for BCN (K254166) | Streck | 2026-03-23 |
| MDx-Chex for BCY (K254167) | Streck, LLC | 2026-03-17 |
| GenBody COVID-19 Ag Home Test (K251916) | Genbody.Inc. | 2026-03-13 |
| Access anti-HBc IgM (K254059) | Beckman Coulter, Inc. | 2026-03-13 |
| QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (K254032) | QIAGEN GmbH | 2026-03-09 |
| Access anti-HBc Total (K253687) | Beckman Coulter, Inc. | 2026-02-19 |
| VELO Respiratory Test (K251742) | Lex Diagnostics Limited | 2026-02-13 |
| Clungene RSV Antigen Rapid Test (K253318) | Hangzhou Clongene Biotech Co., Ltd. | 2026-01-30 |
| Access anti-HAV IgM (K251995) | Beckman Coulter, Inc. | 2026-01-27 |
| PhenoMATRIX (K251511) | Copan Wasp Srl | 2026-01-22 |
| Xpert GI Panel (K251721) | Cepheid | 2026-01-16 |
| Nano-Check Influenza A+B Test (K252283) | Nano-Ditech Corporation | 2026-01-15 |
| Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) (K242492) | Techno-Path Manufacturing , Ltd. | 2025-12-30 |
| LIAISON NES FLU A/B, RSV & COVID-19 (K251978) | Diasorin Molecular, LLC | 2025-12-23 |
| Elecsys Anti-SARS-CoV-2 (K253839) | Roche Diagnostics | 2025-12-17 |
| iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro (K251085) | Ihealth Labs, Inc. | 2025-12-12 |
| iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro (K251092) | Ihealth Labs, Inc. | 2025-12-12 |
| Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 (K251337) | Thermo Fisher Scientific (Oxoid Ltd.) | 2025-12-05 |
| Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip (K251697) | ACON Laboratories, Inc. | 2025-11-26 |
| Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device (K242976) | Medical Wire & Equipment Company (Bath), Ltd. | 2025-11-26 |
| cobas liat Bordetella panel nucleic acid test (K243753) | Roche Molecular Systems, Inc. | 2025-11-20 |
| HardyDisk AST Cefiderocol 30µg (FDC30) (K253105) | Hardy Diagnostics | 2025-11-20 |
| IntelliSep Test (K250912) | Cytovale, Inc. | 2025-11-19 |
| Access Rubella IgG (K250588) | Beckman Coulter, Inc. | 2025-11-17 |
| Status™ COVID-19/Flu A&B (K251538) | Princeton BioMeditech Corp. | 2025-11-14 |
| Lyme-ID IgG Test; Bio-ID800 (K252627) | Inanovate, Inc. | 2025-11-14 |
| cobas CMV (K252481) | Roche Molecular Systems, Inc. | 2025-11-03 |
| cobas HCV (K252484) | Roche Molecular Systems, Inc. | 2025-11-03 |
| 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 (K250358) | Becton, Dickinson and Company | 2025-10-31 |
| Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) (K252387) | Diasorin Molecular, LLC | 2025-10-30 |
| LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (K251875) | Affinity Biosensors, LLC | 2025-10-27 |
| Flowflex Plus RSV + Flu A/B + COVID Home Test (K251749) | ACON Laboratories, Inc. | 2025-10-22 |
| WELLlife COVID-19 Antigen Test Rx (K251289) | Guangzhou Wondfo Biotech Co., Ltd. | 2025-10-22 |
| QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (K252329) | QIAGEN GmbH | 2025-10-22 |
| COVID-19 Detect Rapid Self -Test (K251595) | InBios International, Inc. | 2025-10-12 |
| Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System (K250249) | Gold Standard Diagnostics, LLC | 2025-10-10 |
| MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (K252114) | Liofilchem s.r.l. | 2025-10-02 |
| Visby Medical Men's Sexual Health Test (K251501) | Visby Medical, Inc. | 2025-10-01 |
| miDiagnostics HSV-1&2 CSF Test (K250050) | Midiagnostics NV | 2025-09-30 |
| Panther Fusion GI Bacterial Assay (K251868) | Hologic | 2025-09-25 |
| Panther Fusion GI Expanded Bacterial Assay (K251993) | Hologic, Inc. | 2025-09-25 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL (K252062) | Thermo Fisher Scientific | 2025-09-25 |
| Alinity m HCV (K252102) | Abbott Molecular, Inc. | 2025-09-25 |
| Babio® Virus Transport Kit (Non-inactivating) (K250205) | Jinan Babio Biotechnology Co., Ltd. | 2025-09-22 |
| Access anti-HAV (K243846) | Beckman Coulter, Inc. | 2025-09-09 |
| GenaCheck COVID-19 Rapid Self-Test (K251753) | Genabio Diagnostics, Inc. | 2025-09-05 |
| The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL (K250575) | Thermo Fisher Scientific | 2025-09-05 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL (K252014) | Thermo Fisher Scientific | 2025-08-28 |
| QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini (K250080) | QIAGEN GmbH | 2025-08-27 |
| CareSuperb COVID-19/Flu A&B Antigen Combo Home Test (K251604) | Access Bio, Inc. | 2025-08-22 |
| VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (K251579) | bioMerieux, Inc. | 2025-08-21 |
| MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) (K251580) | Liofilchem s.r.l. | 2025-08-20 |
| MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) (K243804) | Beckman Coulter, Inc. | 2025-08-20 |
| WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test (K251563) | Wondfo USA Co, Ltd. | 2025-08-20 |
| MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) (K250036) | Beckman Coulter, Inc. | 2025-08-15 |
| FilmArray GI Control Panel M238 (K251526) | Maine Molecular Quality Controls, Inc. | 2025-08-14 |
| BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini (K243544) | Biofire Diagnostics, LLC | 2025-08-14 |
| MBT Compass HT CA Software; MBT FAST Shuttle US IVD (K251495) | Bruker Daltonics GmbH & Co. KG | 2025-08-13 |