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| Product | Model | Company | Device type |
|---|---|---|---|
| Product | Model | Company | Device type |
|---|---|---|---|
The Fast PCR Mini Respiratory Panel External Controls are external positive and negative quality control material intended to monitor the performance of the Fast PCR Mini Respiratory Panel that detects and differentiates respiratory targets including SARS-CoV-2, Respiratory Syncytial Virus, Influenza A, and Influenza B in CLIA waived settings. The controls are processed like a patient specimen after rehydration and are used to verify assay, operator and device performance. This material has no assigned quantitative value and is not intended for screening, monitoring or diagnosis of disease. For in vitro diagnostic use only.
| Product | Model | Company | Device type |
|---|---|---|---|
| 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 |
| Alinity mAbbott Molecular Inc.Multiple-genus respiratory virus nucleic acid IVD, control | 09N79-085 | Abbott Molecular Inc. | Multiple-genus respiratory virus nucleic acid IVD, control |
| Simplexa COVID-19 Positive Control PackDiasorin Molecular LLCSARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) | MOL4160 | Diasorin Molecular LLC | SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) |
| SolanaDiagnostic Hybrids, Inc.Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) | M306 | Diagnostic Hybrids, Inc. | Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) |