| Accula SARS-CoV-2 TestMesa Biotech, Inc.SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) | COV4100 | Mesa Biotech, Inc. | SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) |
| Alinity mAbbott Molecular Inc.SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) | 09N78-095 | Abbott Molecular Inc. | SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) |
| 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 |
| Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR ControlLife Technologies CorporationSARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) | 966136 | Life Technologies Corporation | SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) |
| Aptima®Hologic, Inc.SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) | BOX 1, REFRIG, SARS-COV-2 ASSAY, APTIMA 100T, IVD | Hologic, Inc. | SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) |
| cobas liat SARS-CoV-2 v2 nucleic acid testRoche Molecular Systems, Inc.SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) | 09049339190 | Roche Molecular Systems, Inc. | SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) |
| cobas SARS-CoV-2Roche Molecular Systems, Inc.SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) | 09408592190 | Roche Molecular Systems, Inc. | SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) |
| cobas SARS-CoV-2 Quality Control KitRoche Molecular Systems, Inc.SARS-CoV-2 nucleic acid IVD, control | 09408835190 | Roche Molecular Systems, Inc. | SARS-CoV-2 nucleic acid IVD, control |
| cobas® SARS-CoV-2 Qualitative Control KitRoche Molecular Systems, Inc.SARS-CoV-2 nucleic acid IVD, control | 09446117190 | Roche Molecular Systems, Inc. | SARS-CoV-2 nucleic acid IVD, control |
| COVID-19 Coronavirus Real Time PCR KitJiangsu Bioperfectus Technologies Co., Ltd.SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) | 25 Tests | Jiangsu Bioperfectus Technologies Co., Ltd. | SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) |
| Elecsys Anti-SARS-CoV-2 SRoche Diagnostics GmbHSARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay | 09289275190 | Roche Diagnostics GmbH | SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay |
| 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 |
| Fast PCR Mini Respiratory Panel Positive External Control Kits (5 Pos)Autonomous Medical Devices IncorporatedMultiple-genus respiratory virus nucleic acid IVD, control | AMDI-0062 | Autonomous Medical Devices Incorporated | Multiple-genus respiratory virus nucleic acid IVD, control |
| Genedrive(R)96 SARS-CoV2-kitGenedrive Diagnostics LtdSARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) | 1 | Genedrive Diagnostics Ltd | SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) |
| Genedrive(R)96 SARS-CoV2-kitGenedrive Diagnostics LtdSARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) | 1 | Genedrive Diagnostics Ltd | SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) |
| ID NOW COVID-19 2.0Alere Scarborough, Inc.SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) | 192-000 | Alere Scarborough, Inc. | SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) |
| PreciControl Anti-SARS-CoV-2Roche Diagnostics GmbHSARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control | 09216928190 | Roche Diagnostics GmbH | SARS-CoV-2 immunoglobulin G (IgG) antibody 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) |
| Sofia 2Quidel CorporationSARS-CoV-2 antigen IVD, kit, fluorescent immunoassay | 20405 | Quidel Corporation | SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay |
| 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) |
| Solana SARS-CoV-2 AssayDiagnostic Hybrids, Inc.SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) | Coronavirus | Diagnostic Hybrids, Inc. | SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) |
| VITROSOrtho Clinical DiagnosticsSARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay | 6199953 | Ortho Clinical Diagnostics | SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay |