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| Product | Model | Company | Device type |
|---|---|---|---|
| Accula Flu A / B Control KitMesa Biotech, Inc.Thermal cycler nucleic acid amplification analyser IVD, point-of-care | FAB1100CW-C | Mesa Biotech, Inc. | Thermal cycler nucleic acid amplification analyser IVD, point-of-care |
| 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® 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 |
| Fast PCR Mini Respiratory Panel External Control Kits, Small Format (5Pos+5Neg)Autonomous Medical Devices IncorporatedMultiple-genus respiratory virus nucleic acid IVD, control | AMDI-0064 | Autonomous Medical Devices Incorporated | Multiple-genus respiratory virus nucleic acid IVD, control |
| 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) |
| 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) |
| 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 |
| PyloPlus+ Urea Breath Test AnalyzerArj Medical, Inc.Infrared spectrometry breath analyser IVD | PPUBTA-02 | Arj Medical, Inc. | Infrared spectrometry breath analyser IVD |
| PyloPlus+ Urea Breath Test Lab AnalyzerArj Medical, Inc.Infrared spectrometry breath analyser IVD | PPUBTLA-04 | Arj Medical, Inc. | Infrared spectrometry breath analyser IVD |
| 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) |
| QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbHMultiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | V1 | QIAGEN GmbH | Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) |
| Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test CartridgeLuminex CorporationMultiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) | 20-006-024 | Luminex Corporation | Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) |
| Simplexa™ VZV DirectDiasorin Molecular LLCVaricella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT) | MOL3650 | Diasorin Molecular LLC | Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT) |
| xTAG® Cystic Fibrosis (CFTR) 60 kit v2Luminex Molecular Diagnostics, IncCystic fibrosis IVD, kit, multiplex | I024C0181 | Luminex Molecular Diagnostics, Inc | Cystic fibrosis IVD, kit, multiplex |