| Sulopenem SPM 2 µg (K251879) | Liofilchem | 2025-08-12 |
| BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (K251713) | Becton, Dickinson and Company | 2025-08-08 |
| MycoMEIA Aspergillus Assay (K243496) | Pearl Diagnostics, Inc. | 2025-08-01 |
| cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems (K243455) | Roche Molecular Systems, Inc. | 2025-07-31 |
| Alinity m EBV (09N43-095) (K243489) | Abbott Molecular, Inc. | 2025-07-28 |
| MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) (K250084) | Beckman Coulter, Inc. | 2025-07-18 |
| CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) (K243274) | Centers for Disease Control and Prevention | 2025-07-11 |
| Innovita Flu A/B Antigen Rapid Test (K250398) | Innovita (Tangshan) Biological Technology Co., Ltd. | 2025-07-03 |
| Alinity m CMV (K243485) | Abbott Molecular, Inc. | 2025-07-01 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL (K250990) | Thermo Fisher Scientific | 2025-06-30 |
| HardyDisk AST Gepotidacin 10µg (GEP10) (K250956) | Hardy Diagnostics | 2025-06-26 |
| Ceftobiprole BPR 5 µg Disc (K250885) | Liofilchem, Inc. | 2025-06-23 |
| Alinity i Rubella IgG (K243168) | Abbott Laboratories | 2025-06-20 |
| The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. (K242843) | Thermo Fisher Scientific | 2025-06-20 |
| Nano-Check Influenza+COVID-19 Dual Test (K243561) | Nano-Ditech Corporation | 2025-06-17 |
| BD Veritor System for SARS-CoV-2 (K243872) | Becton, Dickinson and Company | 2025-06-16 |
| BinaxNOW COVID-19 Ag Card (K250273) | Abbott Diagnostics Scarborough, Inc. | 2025-06-13 |
| iDart Lyme IgM ImmunoBlot Kit (K242872) | Id-Fish Technology, Inc. | 2025-06-12 |
| ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (K250856) | Biomérieux | 2025-06-12 |
| Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 (K250789) | Thermo Fisher Scientific (Oxoid Ltd.) | 2025-06-12 |
| Elecsys Anti-SARS-CoV-2 (K250768) | Roche Diagnostics | 2025-06-10 |
| LIAISON PLEX Gram-Positive Blood Culture Assay (K243490) | Luminex Corporation | 2025-06-06 |
| NG-Test® CTX-M MULTI (K243499) | Ng Biotech | 2025-06-04 |
| OHC COVID-19 Antigen Self Test (K241313) | Osang, LLC | 2025-05-30 |
| Puritan PurSafe Plus Collection and Transport System (K242820) | Puritan Medical Products, LLC | 2025-05-27 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL (K242659) | Thermo Fisher Scientific | 2025-05-22 |
| BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) (K250447) | Becton, Dickinson and Company | 2025-05-19 |
| HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) (K250454) | Hardy Diagnostics | 2025-05-15 |
| Flowflex Plus COVID-19 + Flu A/B Home Test (K250377) | ACON Laboratories, Inc. | 2025-05-10 |
| DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls (K242294) | Diasys Diagnostic Systems GmbH | 2025-05-09 |
| Teal Wand (DEN240045) | Teal Health, Inc. | 2025-05-09 |
| Xpert Xpress CoV-2/Flu/RSV plus (K250996) | Cepheid® | 2025-05-01 |
| Xpert Xpress CoV-2/Flu/RSV plus (K250995) | Cepheid® | 2025-05-01 |
| ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) (K250274) | Biomerieux S.A. | 2025-04-30 |
| cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (K243406) | Roche Molecular Systems, Inc. | 2025-04-25 |
| cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test (K243400) | Roche Molecular Systems, Inc. | 2025-04-25 |
| BD CTGCTV2 (K243343) | Bd Integrated Diagnostic Solutions/Becton, | 2025-04-22 |
| Acucy® Influenza A&B Test with the Acucy® 2 System (K241188) | SEKISUI Diagnostics, LLC | 2025-04-18 |
| LIAISON PLEX Gram-Negative Blood Culture Assay (K243013) | Luminex Corporation | 2025-04-18 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL (K242658) | Thermo Fisher Scientific | 2025-04-15 |
| cobas liat SARS-CoV-2 v2 nucleic acid test (K243346) | Roche Molecular Systems, Inc. | 2025-04-11 |
| AllTest Viral Transport Medium (K242576) | Hangzhou AllTest Biotech Co., Ltd. | 2025-04-04 |
| Visby Medical Women's Sexual Health Test (DEN240020) | Visby Medical, Inc. | 2025-03-28 |
| Access Toxo IgG (K242022) | Beckman Coulter, Inc. | 2025-03-28 |
| PBC Separator with Selux AST System (K244044) | Selux Diagnostics, Inc. | 2025-03-28 |
| Alinity m BKV (K241921) | Abbott Molecular, Inc. | 2025-03-24 |
| IntelliSep Test (CV-ICG-048) (K250513) | Cytovale, Inc. | 2025-03-21 |
| VITEK COMPACT PRO (K234012) | bioMerieux, Inc. | 2025-03-14 |
| CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) (K243931) | Centers for Disease Control and Prevention | 2025-03-14 |
| BD Phoenix™ Automated Microbiology System (K250344) | Becton, Dickinson and Company | 2025-03-06 |
| Xpert C. difficile/Epi (K243730) | Cepheid® | 2025-02-28 |
| QIAstat-Dx GI Panel 2 Mini B (K250324) | QIAGEN GmbH | 2025-02-28 |
| The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL (K243738) | Thermo Fisher Scientific | 2025-02-27 |
| Visby Medical Respiratory Health Test (K242526) | Visby Medical, Inc. | 2025-02-19 |
| Alinity m Resp-4-Plex (K241573) | Abbott Molecular, Inc. | 2025-02-14 |
| Aptima SARS-CoV-2 Assay (K243396) | Hologic, Inc. | 2025-02-13 |
| ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls (K243575) | Biokit, S.A. | 2025-02-12 |
| BinaxNOW™ COVID-19 Antigen Self Test (K243518) | Abbott Diagnostics Scarborough, Inc. | 2025-02-11 |
| cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems (K240867) | Roche Molecular Systems, Inc. | 2025-02-11 |
| The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL (K243201) | Thermo Fisher Scientific | 2025-02-10 |
| The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL (K242905) | Thermo Fisher Scientific | 2025-02-10 |
| simpli-COLLECT STI Test (K243410) | Abbott Molecular | 2025-01-30 |
| MTS Ceftobiprole 0.002-32 µg/mL (K243202) | Liofilchem s.r.l. | 2025-01-30 |
| CareSuperb™ COVID-19 Antigen Home Test (K241915) | Access Bio, Inc. | 2025-01-29 |
| Aptima CMV Quant Assay (K243935) | Hologic, Inc. | 2025-01-17 |
| cobas® liat CT/NG nucleic acid test (K240217) | Roche Molecular Systems, Inc. | 2025-01-17 |
| cobas® liat CT/NG/MG nucleic acid test (K240197) | Roche Molecular Systems, Inc. | 2025-01-16 |
| WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest (K243256) | Wondfo USA Co, Ltd. | 2025-01-16 |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid (K243885) | Biofire Diagnostics, LLC | 2025-01-16 |
| Xpert® Xpress CoV-2 plus (XPRS-COV2-10) (K242109) | Cepheid® | 2025-01-15 |
| QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test (K243262) | Osang, LLC | 2025-01-13 |
| BioCode Gastrointestinal Pathogen Panel (GPP) (K242877) | Applied BioCode, Inc. | 2025-01-10 |
| Xpert Xpress CoV-2/Flu/RSV plus (K242071) | Cepheid | 2025-01-10 |
| TriVerity (K241676) | Inflammatix, Inc. | 2025-01-10 |
| Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel (K241806) | Life Technologies Corporation | 2025-01-08 |
| QIAstat-Dx GI Panel 2 Mini B&V (K243813) | QIAGEN GmbH | 2025-01-08 |
| DASH® SARS-CoV-2 & Flu A/B Test (K241652) | Nuclein, LLC | 2024-12-20 |
| BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) (K243759) | Biofire Diagnostics, LLC | 2024-12-20 |
| BD Vaginal Panel (K243725) | Becton, Dickinson and Company | 2024-12-19 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL (K243169) | Thermo Fisher Scientific | 2024-12-19 |
| Xpert MRSA/SA SSTI (K243625) | Cepheid® | 2024-12-18 |
| Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) (K241580) | Abbott Molecular | 2024-12-06 |
| BIOFIRE FILMARRAY Tropical Fever Panel (K243463) | Biofire Diagnostics, LLC (Biomerieux) | 2024-12-05 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL (K242653) | Thermo Fisher Scientific | 2024-12-05 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL (K242657) | Thermo Fisher Scientific | 2024-11-26 |
| Aptima BV Assay; Aptima CV/TV Assay (K243345) | Hologic, Inc. | 2024-11-25 |
| Xpert vanA (K243405) | Cepheid® | 2024-11-21 |
| Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (K242465) | Hologic, Inc. | 2024-11-15 |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K242367) | Biofire Diagnostics, LLC | 2024-11-07 |
| QIAstat-Dx Meningitis/Encephalitis (ME) Panel (K242256) | QIAGEN GmbH | 2024-10-29 |
| QIAstat-Dx Respiratory Panel Mini (K242353) | QIAGEN GmbH | 2024-10-25 |
| Xpert® SA Nasal Complete (K243070) | Cepheid® | 2024-10-25 |
| LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (K241324) | Affinity Biosensors, LLC | 2024-10-23 |
| Access Toxo IgM II (K242095) | Beckman Coulter, Inc. | 2024-10-11 |
| PPH Saliva Collection Kit (K240797) | Permantis Public Health | 2024-10-11 |
| UriSponge™ (K232565) | Copan Italia Spa | 2024-10-11 |
| The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml. (K242021) | Thermo Fisher Scientific | 2024-10-09 |
| Healgen Rapid Check COVID-19/Flu A&B Antigen Test (DEN240029) | Healgen | 2024-10-07 |
| NxTAG® Respiratory Pathogen Panel (K242613) | Luminex Molecular Diagnostics, Inc. | 2024-10-02 |
| The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml. (K241967) | Thermo Fisher Scientific | 2024-10-01 |