| Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (K241317) | Guangzhou Wondfo Biotech Co., Ltd. | 2024-09-30 |
| Accelerate Arc System (K240854) | Accelerate Diagnostics, Inc. | 2024-09-26 |
| IVD CAPSULE PSP; abioSCOPE (K240041) | Abionic SA | 2024-09-25 |
| T2Candida 1.1 Panel (K234063) | T2biosystems, Inc. | 2024-09-13 |
| Access Syphilis (K241427) | Beckman Coulter, Inc. | 2024-09-06 |
| Alinity i Toxo IgM (K233932) | Abbott Laboratories | 2024-08-30 |
| Ensol EnTM Specimen Collection and Transport System (K220908) | Ensol Biosciences, Inc. | 2024-08-29 |
| VITROS Immunodiagnostic Products Syphilis Reagent Pack (K241534) | Ortho Clinical Diagnostics | 2024-08-28 |
| SCoV-2 Ag Detect Rapid Test (K233358) | InBios International, Inc. | 2024-08-23 |
| OmniTrans Transport System (K240235) | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 2024-08-19 |
| First To Know Syphilis Test (DEN230090) | Nowdiagnostics | 2024-08-16 |
| iDart Lyme IgG ImmunoBlot Kit (K233367) | Id-Fish Technology, Inc. | 2024-08-12 |
| ADVIA Centaur EBV-EBNA IgG (K233605) | Biokit, S.A. | 2024-08-07 |
| ADVIA Centaur EBV-VCA IgM (K233606) | Biokit, S.A. | 2024-08-07 |
| Viral Transport Medium (K233534) | Hardy Diagnostics | 2024-08-02 |
| Nano-Check™ RSV Test (K240280) | Nano-Ditech Corporation | 2024-07-30 |
| Aptima HCV Quant Dx Assay (K233352) | Hologic, Inc. | 2024-07-24 |
| HardyDisk AST Cefiderocol 30µg (FDC30) (K241060) | Hardy Diagnostics | 2024-07-18 |
| Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay (K241240) | Hologic, Inc. | 2024-07-18 |
| Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) (DEN230092) | Diasorin Molecular, LLC | 2024-07-15 |
| Avantik VTM (K233449) | Hanchang Medic Co., Ltd. (Han Chang Medic) | 2024-07-15 |
| Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit (K233453) | Life Technologies Corporation | 2024-07-10 |
| Xpert HCV; GeneXpert Xpress System (DEN240016) | Cepheid | 2024-06-27 |
| Sample Preservative Fluid (K222771) | Hangzhou Bioer Technology Co., Ltd. | 2024-06-26 |
| CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test (K240728) | CorDx, Inc. | 2024-06-21 |
| VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (K230675) | Specific Diagnostics, LLC | 2024-06-20 |
| Molecular Transport Media - MTM (K233324) | Alb Luz | 2024-06-17 |
| VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (K232967) | bioMerieux, Inc. | 2024-06-12 |
| InActiv Blue (K221547) | Fertipro NV | 2024-06-11 |
| VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (K232963) | bioMerieux, Inc. | 2024-06-07 |
| LIAISON PLEX Yeast Blood Culture Assay (K240627) | Luminex Corporation | 2024-06-04 |
| iHealth COVID-19 Antigen Rapid Test (K233842) | Ihealth Labs, Inc. | 2024-05-31 |
| QIAstat-Dx Gastrointestinal Panel 2 (K220062) | QIAGEN GmbH | 2024-05-31 |
| BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini (K241194) | Biofire Diagnostics, LLC | 2024-05-30 |
| SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control (K241289) | Maine Molecular Quality Controls, Inc. | 2024-05-30 |
| EasyScreen Gastrointestinal Parasite Detection Kit (K232672) | Genetic Signatures Limited | 2024-05-29 |
| CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) (K241110) | Centers for Disease Control and Prevention | 2024-05-21 |
| The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml. (K240445) | Thermo Fisher Scientific | 2024-05-16 |
| QIAstat-Dx® Respiratory Panel Plus (K233100) | QIAGEN GmbH | 2024-05-10 |
| Alinity m HSV 1 & 2 / VZV (K233349) | Abbott Molecular, Inc. | 2024-05-03 |
| Viral Transport Media (VTM) (K232454) | Alb Luz | 2024-05-03 |
| ASTar BC G- Kit and ASTar Instrument (K221688) | Q-Linea AB | 2024-04-26 |
| Copan Universal Transport Medium (UTM-RT) System (K232357) | Copan Italia Spa | 2024-04-25 |
| Healgen Rapid COVID-19 Antigen Test (K232377) | Healgen Scientific,, LLC | 2024-04-19 |
| Flowflex® Plus COVID-19 Home Test (K233373) | ACON Laboratories, Inc. | 2024-04-19 |
| Azer Scientific Universal Transport Medium (K202531) | Azer Scientific, Inc. | 2024-04-11 |
| Sample preservation solution (K212878) | Zhejiang Gene Science Co., Ltd. | 2024-04-08 |
| LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System (K211815) | Affinity Biosensors | 2024-04-02 |
| ARX Liquid Amies Collection & Transport System (K222613) | Arx Sciences, Inc. | 2024-03-27 |
| SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) (K233611) | Maine Molecular Quality Controls, Inc. | 2024-03-26 |
| BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel (K232954) | Biofire Diagnostics, LLC | 2024-03-26 |
| QuickVue COVID-19 Test (K231795) | Quidel Corporation | 2024-03-22 |
| Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 (K231806) | Oxoid Limited (Part of Thermo Fisher Scientific) | 2024-03-22 |
| ARX Viral Transport Media Collection and Transport System (K231843) | Arx Sciences, Inc. | 2024-03-19 |
| BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) (K233986) | Becton, Dickinson and Company | 2024-03-15 |
| NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) (K231758) | Luminex Molecular Diagnostics, Inc. | 2024-03-11 |
| VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (K234000) | bioMerieux, Inc. | 2024-03-11 |
| LIAISON PLEX Respiratory Flex Assay (K233410) | Luminex Corporation | 2024-03-01 |
| PBC Separator with Selux AST System (K223493) | Selux Diagnostics, Inc. | 2024-02-15 |
| eQUANT System (K231536) | Avails Medical, Inc. | 2024-02-08 |
| T2Bacteria® Panel (K233184) | T2biosystems, Inc. | 2024-02-08 |
| Aptima Neisseria gonorrhoeae Assay (K231329) | Hologic, Inc. | 2024-01-26 |
| Nano-Check™ COVID-19 Antigen Test (K231187) | Nano-Ditech Corporation | 2024-01-23 |
| Colibrí (K232756) | Copan Wasp Srl | 2023-12-27 |
| NeuMoDx CT/NG Assay 2.0 (K230267) | Neumodx Molecular, Inc. | 2023-12-22 |
| KaiBiLi Extended ViralTrans (K231027) | Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | 2023-12-21 |
| Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument (K232286) | Quidel Corporation | 2023-12-20 |
| SeptiCyte RAPID (K232095) | Immunexpress, Inc. | 2023-12-15 |
| Hp Detect™ Stool Antigen ELISA (K232892) | Biomerica, Inc. | 2023-12-15 |
| Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set (K233688) | Quidel Corporation | 2023-12-13 |
| BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit (K232434) | Bd | 2023-12-05 |
| cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (K223783) | Roche Molecular Systems, Inc. | 2023-12-04 |
| Cue COVID-19 Molecular Test (K232643) | Cue Health, Inc. | 2023-11-28 |
| The SensiTox B. anthracis Toxin Test (K232545) | First Light Diagnostics, Inc. | 2023-11-20 |
| Aptima® Chlamydia trachomatis Assay (K230451) | Hologic, Inc. | 2023-11-16 |
| Simple 2 Test (DEN200070) | Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) | 2023-11-15 |
| Great Basin Toxigenic C. difficile Direct Test (CDF2) (K232092) | Vela Operations USA | 2023-11-14 |
| Flowflex COVID-19 Antigen Home Test (K230828) | ACON Laboratories, Inc. | 2023-11-09 |
| Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml (K232310) | Thermo Fisher Scientific | 2023-10-31 |
| LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (K231214) | DiaSorin, Inc. | 2023-10-27 |
| VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin (K232201) | bioMerieux, Inc. | 2023-10-23 |
| Xpert Xpress MVP; GeneXpert Xpress System (K231381) | Cepheid | 2023-10-19 |
| Xpert® Xpress CoV-2 plus (K230440) | Cepheid® | 2023-10-13 |
| ID NOW Influenza A & B 2 (K232775) | Abbott Diagnostics Scarborough, Inc. | 2023-10-10 |
| Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 (K232276) | Oxoid Limited (Part of Thermo Fisher Scientific) | 2023-10-06 |
| ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD (K232395) | Biomérieux | 2023-10-05 |
| DYNEX SmartPLEX MMRV IgG Assay Kit (K212769) | Dynex Technologies, Inc. | 2023-09-29 |
| DNA/RNA Shield SafeCollect Saliva Collection kit (K231013) | Zymo Research | 2023-09-28 |
| Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems (K222638) | Cepheid | 2023-09-27 |
| ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls (K213987) | Biokit, S.A. | 2023-09-20 |
| The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL (K231433) | Thermo Fisher Scientific | 2023-08-31 |
| BD Kiestra IdentifA (K222563) | Becton, Dickinson and Company | 2023-08-31 |
| Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml (K231988) | Thermo Fisher Scientific | 2023-08-30 |
| Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL (K231994) | Thermo Fisher Scientific | 2023-08-25 |
| Xpert Xpress CoV-2/Flu/RSV plus (K231481) | Cepheid® | 2023-08-17 |
| ID NOW COVID-19 2.0 (K221925) | Abbott Diagnostics Scarborough, Inc. | 2023-08-10 |
| HAVAb IgG II (K222850) | Abbott Laboratories | 2023-08-10 |
| BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System (K230956) | Bd Integrated Diagnostic Solutions / | 2023-07-31 |
| MDx-Chex for BC-GP (K231221) | Streck | 2023-07-27 |
| cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System (K223591) | Roche Molecular Systems, Inc. | 2023-07-27 |