Covid-19 multi-analyte antigen device / Simple point-of-care device to directly detect sars-cov-2 viral targets from clinical specimens in near-patient settings

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Product	Model	Company	Device type
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
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
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
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
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
OSOM RSV TestSekisui Diagnostics, LLCRespiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical	1091	Sekisui Diagnostics, LLC	Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
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
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
SofiaQuidel CorporationMultiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay	20377	Quidel Corporation	Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
Sofia 2Quidel CorporationSARS-CoV-2 antigen IVD, kit, fluorescent immunoassay	20405	Quidel Corporation	SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay
WELLlife™Wondfo USA Co., Ltd.SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing	WV01P0001-1	Wondfo USA Co., Ltd.	SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
WELLlife™Wondfo USA Co., Ltd.SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical	WCOV-POC-T25C1	Wondfo USA Co., Ltd.	SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical