| Alethia™ CMVMeridian Bioscience, Inc.Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) | 481325 | Meridian Bioscience, Inc. | Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) |
| BD MAX™ Extended Enteric Bacterial PanelBecton, Dickinson and CompanyMultiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) | 443812 | Becton, Dickinson and Company | Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) |
| BioFire Warrior PanelBiofire Defense, LLCMultiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | NGDS-ASY-0018 | Biofire Defense, LLC | Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) |
| BIOFIRE® FILMARRAY® Tropical Fever PanelBiofire Diagnostics, LLCMultiple-type tropical pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | 424803 | Biofire Diagnostics, LLC | Multiple-type tropical pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) |
| BioFire® Global Fever PanelBiofire Defense, LLCMultiple-type tropical pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | DFA2-ASY-0004 | Biofire Defense, LLC | Multiple-type tropical pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) |
| BioFire® Joint Infection (JI) PanelBiofire Diagnostics, LLCMultiple-type osteoarticular pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | RFIT-ASY-0138 | Biofire Diagnostics, LLC | Multiple-type osteoarticular pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) |
| BioFire® Joint Infection (JI) PanelBiofire Diagnostics, LLCMultiple-type osteoarticular pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | RFIT-ASY-0135 | Biofire Diagnostics, LLC | Multiple-type osteoarticular pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) |
| BioFire® Respiratory Panel 2.1-EZ EUA, 30 TestsBiofire Diagnostics, LLCMultiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | 423883 | Biofire Diagnostics, LLC | Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) |
| BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens PaneBiofire Defense, LLCMultiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control | DFA2-ASY-0019 | Biofire Defense, LLC | Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control |
| cobas Liat Strep A Script Version 1.27Roche Molecular Systems, Inc.Laboratory instrument/analyser application software IVD | 08403856001 | Roche Molecular Systems, Inc. | Laboratory instrument/analyser application software IVD |
| cobas® Liat® Strep A ScriptRoche Molecular Systems, Inc.Laboratory instrument/analyser application software IVD | 08085471001 | Roche Molecular Systems, Inc. | Laboratory instrument/analyser application software IVD |
| cobas® Strep A Nucleic acid test for use on the cobas® Liat® SystemRoche Molecular Systems, Inc.Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) | 07341911190 | Roche Molecular Systems, Inc. | Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) |
| FilmArray® Gastrointestinal (GI) PanelBiofire Diagnostics, LLCMultiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | RFIT-ASY-0104 | Biofire Diagnostics, LLC | Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) |
| FilmArray® Meningitis/Encephalitis (ME) PanelBiofire Diagnostics, LLCMultiple-type meningitis pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | RFIT-ASY-0119 | Biofire Diagnostics, LLC | Multiple-type meningitis pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) |
| FilmArray® Pneumonia Panel (Pneumo)Biofire Diagnostics, LLCMultiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | RFIT-ASY-0144 | Biofire Diagnostics, LLC | Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) |
| FilmArray® Pneumonia Panel (Pneumo)Biofire Diagnostics, LLCMultiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | RFIT-ASY-0145 | Biofire Diagnostics, LLC | Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) |
| FilmArray® Pneumonia Panel plus (Pneumoplus)Biofire Diagnostics, LLCMultiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | RFIT-ASY-0142 | Biofire Diagnostics, LLC | Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) |
| LyraQuidel CorporationMultiple human parainfluenza virus nucleic acid IVD, kit, nucleic acid technique (NAT) | Parainfluenza Virus Assay | Quidel Corporation | Multiple human parainfluenza virus nucleic acid IVD, kit, nucleic acid technique (NAT) |
| NG-Test CARBA 5Ng BiotechBacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit | Kit of 20 tests for US | Ng Biotech | Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit |
| Panther Fusion®Hologic, Inc.Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) | SPECIMEN LYSIS TUBES, IVD | Hologic, Inc. | Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) |
| Panther Fusion®Hologic, Inc.Nucleic acid technique (NAT) kit IVD | RECON-1 KIT, PANTHER FUSION, 1920T, IVD | Hologic, Inc. | Nucleic acid technique (NAT) kit IVD |
| Panther Fusion®Hologic, Inc.Nucleic acid technique (NAT) kit IVD | EXTRACTION REAGENT-X, 960T, IVD | Hologic, Inc. | Nucleic acid technique (NAT) kit IVD |
| Panther Fusion®Hologic, Inc.Exogenous DNA/RNA internal control IVD, kit | INTERNAL CONTROL-X, 960T, IVD | Hologic, Inc. | Exogenous DNA/RNA internal control IVD, kit |
| QIAstat-Dx® Gastrointestinal Panel 2QIAGEN GmbHMultiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | V1 | QIAGEN GmbH | Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) |
| QIAstat-Dx® Meningitis/Encephalitis (ME) PanelQIAGEN GmbHMultiple-type meningitis pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | V2 | QIAGEN GmbH | Multiple-type meningitis pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) |