| MDx-Chex for BC-GN (K231223) | Streck | 2023-07-27 |
| ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit (K230863) | Zeus Scientific | 2023-07-13 |
| HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) (K231568) | Hardy Diagnostics | 2023-07-06 |
| VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (K230864) | bioMerieux, Inc. | 2023-07-05 |
| Premier HpSA Flex (619096) (K230901) | Meridian Bioscience, Inc. | 2023-07-03 |
| CLEARinse CTS Specimen Collection and Transport System (K221664) | Aardvark Medical, Inc. | 2023-07-03 |
| Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae) (K230935) | Thermo Fisher Scientific | 2023-06-30 |
| FebriDx Bacterial / Non-bacterial Point of Care Assay (K230917) | Lumos Diagnostics, Inc. | 2023-06-30 |
| MeMed BV (K230944) | MeMed Diagnostics, Ltd. | 2023-06-30 |
| VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) (K222378) | bioMerieux, Inc. | 2023-06-26 |
| BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20) (K230651) | Becton, Dickinson and Company | 2023-06-07 |
| Cue COVID-19 Molecular Test (DEN220028) | Cue Health, Inc. | 2023-06-06 |
| cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems (K231306) | Roche Molecular Systems, Inc. | 2023-06-01 |
| HardyDisk AST Rezafungin 5µg (RZF5) (K230827) | Hardy Diagnostics | 2023-06-01 |
| ComASP Cefiderocol 0.008-128 (K230479) | Liofilchem s.r.l. | 2023-05-18 |
| Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay (K222736) | Hologic, Inc. | 2023-05-16 |
| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators (DEN210040) | Ortho-Clinical Diagnostics, Inc. | 2023-05-05 |
| Panther Fusion AdV/hMPV/RV Assay (K231017) | Hologic, Inc. | 2023-05-05 |
| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator (DEN210038) | Ortho-Clinical Diagnostics, Inc. | 2023-05-05 |
| BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App (K213280) | Bd Kiestra B.V. | 2023-05-04 |
| MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System (K212743) | Medschenker, Inc. | 2023-05-03 |
| Access PCT (K222996) | Beckman Coulter, Inc. | 2023-04-26 |
| Selux AST System; Model AST Gen 1.0 (K211748) | Selux Diagnostics, Inc. | 2023-04-19 |
| Curian® Shiga Toxin (K222829) | Meridian Bioscience, Inc. | 2023-04-17 |
| SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control (K230868) | Maine Molecular Quality Controls, Inc. | 2023-04-13 |
| BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini (K230719) | Biofire Diagnostics, LLC | 2023-04-13 |
| MicroScan Prompt Inoculation System-D (K221493) | Beckman Coulter, Inc. | 2023-04-05 |
| BioSci™ Disposable Virus Sampling Tubes (K230035) | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 2023-04-05 |
| iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) (K221802) | Mawi Dna Technologies | 2023-04-03 |
| BD BACTEC™ Plus Aerobic/F Culture Vials (K222591) | Becton, Dickinson and Company | 2023-03-24 |
| BD BACTEC™ Myco/F Lytic Culture Vials (K222559) | Becton, Dickinson and Company | 2023-03-24 |
| MeMed BV (K222332) | MeMed Diagnostics, Ltd. | 2023-03-23 |
| Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae) (K223844) | Thermo Fisher Scientific | 2023-03-21 |
| Colibrí (K223245) | Copan Wasp Srl | 2023-03-20 |
| Simplexa COVID-19 & Flu A/B Direct (K220963) | Diasorin Molecular, LLC | 2023-03-17 |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K230404) | Biofire Diagnostics, LLC | 2023-03-16 |
| Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL (K221198) | Thermo Fisher Scientific | 2023-03-10 |
| Lyra RSV+hMPV Assay (K230349) | Quidel Corporation | 2023-03-10 |
| VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (K222430) | Biomerieux Sa, Inc. | 2023-03-09 |
| Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set (DEN220039) | Quidel Corporation | 2023-03-08 |
| Visby Medical Sexual Health Test (K220407) | Visby Medical | 2023-03-07 |
| BD Vaginal Panel (K223653) | Becton, Dickinson and Company | 2023-03-06 |
| Lyra Influenza A+B Assay (K230236) | Quidel Corporation | 2023-03-03 |
| Alinity m STI Assay (K222379) | Abbott Molecular, Inc. | 2023-03-03 |
| Spectrum Saliva Collection Device (K223497) | Spectrum Solutions, LLC | 2023-02-17 |
| VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (K223478) | bioMerieux, Inc. | 2023-02-16 |
| VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) (K222073) | bioMerieux, Inc. | 2023-02-09 |
| SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control (K221253) | Maine Molecular Quality Controls, Inc. | 2023-02-03 |
| Active Anthrax DetectTM Plus Rapid Test (DEN220044) | InBios International, Inc. | 2023-02-03 |
| BIOFIRE SPOTFIRE Respiratory (R) Panel (K213954) | Biofire Diagnostics | 2023-02-03 |
| VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) (K223481) | bioMerieux, Inc. | 2023-02-03 |
| VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin (K220803) | bioMerieux, Inc. | 2023-01-27 |
| BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (K223016) | Bd | 2023-01-27 |
| The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml (K221899) | Thermo Fisher Scientific | 2023-01-20 |
| Biosci™ Inactivated Transport Medium, Biosci™ ITM (K220059) | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 2023-01-19 |
| Selux AST System; Model AST Gen 1.0 (K211759) | Selux Diagnostics, Inc. | 2023-01-18 |
| Elecsys Anti-HCV II (08837031190) (K221693) | Roche Diagnostics | 2023-01-04 |
| BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) (K221826) | Becton, Dickinson and Company | 2022-12-21 |
| IntelliSep test (K220991) | Cytovale, Inc. | 2022-12-20 |
| BreathID Hp System (K221896) | Meridian Bioscience Israel , Ltd. | 2022-12-19 |
| Copan FecalSwab Collection, Transport and Preservation System (K220052) | Copan Italia Spa | 2022-12-16 |
| LIAISON Anti-HAV; LIAISON XS (K223403) | DiaSorin, Inc. | 2022-12-09 |
| Disposable Urine Collection Tube (K220739) | Zhejiang Gongdong Medical Technology Co., Ltd. | 2022-11-17 |
| BreathID® Smart System (K223185) | Meridian Bioscience Israel , Ltd. | 2022-11-10 |
| Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack (K202755) | Diasorin Molecular, LLC | 2022-11-05 |
| cobas HCV (K221007) | Roche Molecular Systems, Inc. | 2022-11-04 |
| Architect CMV IgG (K220949) | Abbott Laboratories | 2022-10-27 |
| cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems (K213804) | Roche Molecular Systems, Inc. | 2022-10-22 |
| BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel (K220870) | Biofire Defense, LLC | 2022-10-20 |
| VITEK 2 AST-Gram Positive Cefoxitin Screen (K220805) | bioMerieux, Inc. | 2022-10-13 |
| Elecsys CMV IgG (K220911) | Roche Diagnostics | 2022-10-12 |
| Elecsys HSV-2 IgG (08948887160) (K220924) | Roche Diagnostics | 2022-10-12 |
| Elecsys HSV-1 IgG (08948844160) (K220923) | Roche Diagnostics | 2022-10-12 |
| Colibrí System (K220546) | Copan Wasp Srl | 2022-10-05 |
| BD MAX Enteric Viral Panel (K220607) | Becton, Dickinson and Company | 2022-09-21 |
| Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 (K203336) | Oxoid Limited (Part of Thermo Fisher Scientific) | 2022-09-15 |
| Simplexa COVID-19 Direct (K212147) | Diasorin Molecular, LLC | 2022-09-13 |
| Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K222558) | Centers for Disease Control and Prevention | 2022-08-30 |
| Dimension EXL LOCI BRAHMS Procalcitonin (PCT) (K220262) | Siemens Healthcare Diagnostics, Inc. | 2022-08-26 |
| BD MAX Enteric Parasite Panel (K220193) | Becton, Dickinson and Company | 2022-08-19 |
| Viramed Borrela All-In-One ViraChip Test Kit (K220016) | Viramed Biotech AG | 2022-08-19 |
| iClean Viral Transport System (VTM-RT kit) (K212856) | Huachenyang (Shenzhen) Technology Co. , Ltd. | 2022-08-18 |
| Dasky Disposable Sampling Tube (Model name: VSM02) (K211675) | Ningbo Dasky Life Science Co., Ltd. | 2022-08-08 |
| VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL) (K212243) | bioMerieux, Inc. | 2022-08-08 |
| MagXtract Collection Tube (K212113) | Magbio Genomics, Inc. | 2022-07-28 |
| BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel (K214122) | Becton, Dickinson and Company | 2022-07-28 |
| BioFire COVID-19 Test 2 (K221460) | Biofire Defense, LLC | 2022-07-25 |
| BioFire JI Control Panel M420 (K203680) | Maine Molecular Quality Controls, Inc. | 2022-07-22 |
| Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) (K212778) | Abbott Molecular, Inc. | 2022-07-15 |
| LIAISON MeMed BV, LIAISON MeMed BV Control Set (K213936) | DiaSorin, Inc. | 2022-07-14 |
| VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (K213899) | bioMerieux, Inc. | 2022-07-12 |
| cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System (K213822) | Roche Molecular Systems, Inc. | 2022-07-06 |
| Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K221834) | Centers for Disease Control and Prevention | 2022-06-24 |
| ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 (K220801) | Abbott Diagnostics Scarborough, Inc. | 2022-06-24 |
| BreathID Hp Lab System, BreathID Smart System (K220494) | Meridian Bioscience Israel , Ltd. | 2022-06-23 |
| Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K221658) | Centers for Disease Control and Prevention | 2022-06-10 |
| Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (K221160) | Cepheid | 2022-06-07 |
| Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris (K220321) | Hologic, Inc. | 2022-06-03 |
| VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) (K213931) | bioMerieux, Inc. | 2022-06-03 |
| Disposable Sampler Viral Transport Media (K211256) | Wuxi Nest Biotechnology Co., Ltd. | 2022-05-20 |