| Accelerate PhenoTest BC KitMultiplex | Accelerate Diagnostics | | Accelerate Pheno | 7 hr | 510(k) | CE-IVD | |
| ADVIA Centaur HIV Ag/Ab Combo | Siemens Healthineers | | ADVIA Centaur | 35 min | PMA | CE-IVD | |
| Alinity m Resp-4-PlexMultiplex | Abbott Diagnostics | | Alinity m | 2.5 hr | EUA | CE-IVD | |
| Alinity m SARS-CoV-2 AMP Kit | Abbott Diagnostics | | Alinity m | 2.5 hr | EUA | CE-IVD | |
| Allplex SARS-CoV-2/FluA/FluB/RSV AssayMultiplex | Seegene | | CFX96 | 2 hr | EUA | CE-IVD | |
| Allplex STI Essential AssayMultiplex | Seegene | | CFX96 | 2.5 hr | RUO | CE-IVD | |
| Applied Biosystems HIV-1 Genotyping Kit | Thermo Fisher Scientific | | Applied Biosystems 3500xL | 8 hr | PMA | CE-IVD | |
| Aptima Combo 2 Assay | Hologic | | Panther | 3 hr | 510(k) | CE-IVD | |
| Aptima HIV-1 Quant Dx Assay | Hologic | | Panther | 3 hr | PMA | CE-IVD | |
| Aptima Trichomonas vaginalis Assay | Hologic | | Panther | 3 hr | 510(k) | CE-IVD | |
| Architect HIV Ag/Ab Combo | Abbott Diagnostics | | ARCHITECT | 30 min | PMA | CE-IVD | |
| artus HCV RG RT-PCR Kit | Qiagen | | Rotor-Gene Q | 3 hr | RUO | CE-IVD | |
| BD MAX CT/GC/TVMultiplex | Becton Dickinson (BD) | | BD MAX | 3.5 hr | 510(k) | CE-IVD | |
| BD MAX MRSA XT Assay | Becton Dickinson (BD) | | BD MAX | 3 hr | 510(k) | CE-IVD | |
| BD Phoenix NMIC/ID-96 Panel | Becton Dickinson (BD) | | BD Phoenix | 8 hr | 510(k) | CE-IVD | |
| BD Veritor System Flu A+BMultiplex | Becton Dickinson (BD) | | BD Veritor | 15 min | 510(k) | CE-IVD | |
| BinaxNOW COVID-19 Antigen Card | Abbott Diagnostics | | BinaxNOW | 15 min | EUA | CE-IVD | |
| BIOFIRE FILMARRAY Blood Culture Identification Panel 2Multiplex | bioMérieux | | BIOFIRE FILMARRAY | 1 hr | 510(k) | CE-IVD | |
| BIOFIRE FILMARRAY GI PanelMultiplex | bioMérieux | | BIOFIRE FILMARRAY | 1 hr | 510(k) | CE-IVD | |
| BIOFIRE FILMARRAY Meningitis/Encephalitis PanelMultiplex | bioMérieux | | BIOFIRE FILMARRAY | 1 hr | 510(k) | CE-IVD | |
| BIOFIRE FILMARRAY Respiratory Panel 2.1Multiplex | bioMérieux | | BIOFIRE FILMARRAY | 45 min | 510(k) | CE-IVD | |
| BIOFIRE FILMARRAY Tropical Fever PanelMultiplex | bioMérieux | | BIOFIRE FILMARRAY | 1 hr | RUO | CE-IVD | |
| cobas HCV Quantitative Nucleic Acid Test | Roche Diagnostics | | cobas 6800/8800 | 4 hr | PMA | CE-IVD | |
| cobas HIV-1/HIV-2 Qualitative Test | Roche Diagnostics | | cobas 6800/8800 | 4 hr | PMA | CE-IVD | |
| cobas Liat Influenza A/B & RSVMultiplex | Roche Diagnostics | | cobas Liat | 20 min | 510(k) | CE-IVD | |
| cobas MTB/RIF | Roche Diagnostics | | cobas Liat | 1 hr | 510(k) | CE-IVD | |
| cobas SARS-CoV-2 & Influenza A/BMultiplex | Roche Diagnostics | | cobas 6800/8800 | 3.5 hr | EUA | CE-IVD | |
| DPP HIV 1/2 Assay | Chembio Diagnostics | | DPP (Dual Path Platform) | 15 min | PMA | CE-IVD | |
| DPP Syphilis Screen & Confirm | Chembio Diagnostics | | DPP (Dual Path Platform) | 15 min | 510(k) | CE-IVD | |
| ePlex Blood Culture Identification Gram-Positive PanelMultiplex | GenMark Diagnostics (Roper Technologies) | | ePlex | 1.5 hr | 510(k) | CE-IVD | |
| ePlex Respiratory Pathogen Panel 2Multiplex | GenMark Diagnostics (Roper Technologies) | | ePlex | 1.5 hr | EUA | CE-IVD | |
| ID NOW Strep A 2 | Abbott Diagnostics | | ID NOW | 6 min | 510(k) | CE-IVD | |
| LIAISON MDX SARS-CoV-2 Ag | DiaSorin | | LIAISON MDX | 30 min | EUA | CE-IVD | |
| MALDI Biotyper CA System | Bruker | | MALDI-TOF MS | 15 min | 510(k) | CE-IVD | |
| Meridian Illumigene C. difficile | Meridian Bioscience | | illumipro-10 | 1 hr | 510(k) | CE-IVD | |
| NxTAG Respiratory Pathogen PanelMultiplex | Luminex (DiaSorin Molecular) | | MAGPIX | 5 hr | 510(k) | CE-IVD | |
| QIAstat-Dx Gastrointestinal PanelMultiplex | Qiagen | | QIAstat-Dx | 1 hr | 510(k) | CE-IVD | |
| QIAstat-Dx Respiratory SARS-CoV-2 PanelMultiplex | Qiagen | | QIAstat-Dx | 1 hr | EUA | CE-IVD | |
| QuantiFERON-TB Gold Plus | Qiagen | | ELISA | 24 hr | 510(k) | CE-IVD | |
| Sentosa SA SARS-CoV-2 Assay | Vela Diagnostics | | Sentosa SA | 3 hr | EUA | CE-IVD | |
| STANDARD Q COVID-19 Ag Test | SD Biosensor | | STANDARD Q | 15 min | EUA | CE-IVD | |
| STANDARD Q Dengue Duo Ag/Ab ComboMultiplex | SD Biosensor | | STANDARD Q | 20 min | 510(k) | CE-IVD | |
| STANDARD Q Malaria P.f/Pan Ag TestMultiplex | SD Biosensor | | STANDARD Q | 20 min | 510(k) | CE-IVD | |
| TaqPath COVID-19 Combo KitMultiplex | Thermo Fisher Scientific | | Applied Biosystems 7500 Fast Dx | 2 hr | EUA | CE-IVD | |
| Unyvero HPN Hospitalized Pneumonia PanelMultiplex | Curetis (OpGen) | | Unyvero | 5 hr | 510(k) | CE-IVD | |
| Xpert Flu/RSV XCMultiplex | Cepheid (Danaher) | | GeneXpert | 30 min | 510(k) | CE-IVD | |
| Xpert HIV-1 Qual | Cepheid (Danaher) | | GeneXpert | 90 min | PMA | CE-IVD | |
| Xpert MRSA/SA SSTIMultiplex | Cepheid (Danaher) | | GeneXpert | 70 min | 510(k) | CE-IVD | |
| Xpert MTB/RIF Ultra | Cepheid (Danaher) | | GeneXpert | 80 min | 510(k) | CE-IVD | |
| Xpert Norovirus | Cepheid (Danaher) | | GeneXpert | 30 min | RUO | CE-IVD | |