| BinaxNOW COVID-19 Antigen Self TestAlere Scarborough, Inc.SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing | 195-267 | Alere Scarborough, Inc. | SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing |
| BinaxNOW COVID-19/Flu A&B Combo Self TestAlere Scarborough, Inc.Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing | 20002608 | Alere Scarborough, Inc. | Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing |
| BinaxNOW RSV Control Swab KitAlere Scarborough, Inc.Respiratory syncytial virus (RSV) antigen IVD, control | 430-080 | Alere Scarborough, Inc. | Respiratory syncytial virus (RSV) antigen IVD, control |
| Bio-Self COVID-19 Antigen Home TestBioteke USA, LLCSARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing | BTK-H2201 | Bioteke USA, LLC | SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing |
| CVS HealthWoonsocket Prescription Center, IncorporatedMultiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing | 641986 | Woonsocket Prescription Center, Incorporated | Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing |
| equateWal-Mart Stores, Inc.SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing | ICO-3000 | Wal-Mart Stores, Inc. | SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing |
| Fluoro-Check TM COVID-19 Antigen TestNano-Ditech CorporationSARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing | TF-8150 | Nano-Ditech Corporation | SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing |
| GenaCheck® COVID-19 Rapid Self-Test 2TGenabio Diagnostics Inc.SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing | — | Genabio Diagnostics Inc. | SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing |
| Helix Elite™ Molecular Standards: Inactivated StandardMicrobiologics Inc.SARS-CoV-2 antigen IVD, control | HE0068AG | Microbiologics Inc. | SARS-CoV-2 antigen IVD, control |
| iHealthiHealth Labs Inc.Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing | ICF-3000 | iHealth Labs Inc. | Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing |
| iHealthiHealth Labs Inc.Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing | ICF-3000 | iHealth Labs Inc. | Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing |
| iHealthiHealth Labs Inc.SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing | ICO-3000 | iHealth Labs Inc. | SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing |
| iHealthiHealth Labs Inc.SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing | ICO-3000 | iHealth Labs Inc. | SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing |
| ImmuView COVID-19 Antigen Home TestCtk Biotech Inc.SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing | R0182CHT-2T | Ctk Biotech Inc. | SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing |
| INDICAID COVID-19 Rapid Antigen At-Home TestPhase Scientific International LimitedSARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing | 2-Test | Phase Scientific International Limited | SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing |
| McKessonMckesson Medical-Surgical Inc.Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing | GCCOV-502a-MB | Mckesson Medical-Surgical Inc. | Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing |
| McKessonMckesson Medical-Surgical Inc.Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing | CCOVAg-PNMB | Mckesson Medical-Surgical Inc. | Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing |
| Nano-Check TM COVID-19 Antigen TestNano-Ditech CorporationSARS-CoV-2 antigen IVD, kit, rapid ICT, clinical | MD-8147 | Nano-Ditech Corporation | SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical |
| Nano-Check™ COVID-19 Antigen Control KitNano-Ditech CorporationSARS-CoV-2 antigen IVD, control | MD-8147EX | Nano-Ditech Corporation | SARS-CoV-2 antigen IVD, control |
| QuickFinder™ COVID-19/Flu Antigen Self TestOSANG HEALTHCARE Co., Ltd.Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing | OI-01SU-CC | OSANG HEALTHCARE Co., Ltd. | Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing |
| QuickProfile™ 2019-nCoV IgG/IgM Antibody TestLumiquick Diagnostics, Inc.SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical | 71108B | Lumiquick Diagnostics, Inc. | SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical |
| QuickProfile™ Covid-19/FluA&B Antigen Combo TestLumiquick Diagnostics, Inc.Influenza A/B virus antigen IVD, kit, rapid ICT, clinical | 71118-1T | Lumiquick Diagnostics, Inc. | Influenza A/B virus antigen IVD, kit, rapid ICT, clinical |
| RDB6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)WatMIND USASARS-CoV-2 antigen IVD, kit, rapid ICT, clinical | RDB6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box) | WatMIND USA | SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical |
| SCoV-2 Ag Detect™ Rapid TestInbios International, IncSARS-CoV-2 antigen IVD, kit, rapid ICT, clinical | COVAF-50 | Inbios International, Inc | SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical |
| SofiaQuidel CorporationMultiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay | 20377 | Quidel Corporation | Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay |