Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Ag Card Home Test
Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Antigen Self Test
Access Bio, Inc.: CareStart COVID-19 Antigen Home Test
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ACON Laboratories, Inc: Flowflex COVID-19 Antigen Home Test
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Aptitude Medical Systems Inc.: Metrix COVID-19 Test
Celltrion USA, Inc.: Celltrion DiaTrust COVID-19 Ag Home Test
CTK Biotech, Inc.: ImmuView COVID-19 Antigen Home Test
Cue Health Inc.: Cue COVID-19 Test for Home and Over The Counter (OTC) Use
Ellume Limited: Ellume COVID-19 Home Test
Genabio Diagnostics Inc.: Genabio COVID-19 Rapid Self-Test Kit
iHealth Labs, Inc.: iHealth COVID-19 Antigen Rapid Test
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InBios International Inc: SCoV-2 Ag Detect Rapid Self-Test
Immunostics Inc.: Swab-N-Go Home Test COVID-19 Ag
PfizerInc: Lucira CHECK-IT COVID-19 Test Kit
Maxim Biomedical, Inc.: MaximBio ClearDetect COVID-19 Antigen Home Test
Mologic, Inc.: COVI-Go SARS-CoV-2 Ag Self-Test
OraSure Technologies, Inc.: InteliSwab COVID-19 Rapid Test
OSANG LLC: OHC COVID-19 Antigen Self Test
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PHASE Scientific International, Ltd.: INDICAID COVID-19 Rapid Antigen At-Home Test
Quidel Corporation: QuickVue At-Home OTC COVID-19 Test
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SD Biosensor, Inc.: Pilot COVID-19 At-Home Test
FDA Safety Communication - Recall of Certain Lots
Siemens Healthineers: CLINITEST Rapid COVID-19 Antigen Self-Test
Watmind USA: Speedy Swab Rapid COVID-19 Antigen Self-Test
Xiamen Boson Biotech Co., Ltd.: Rapid SARS-CoV-2 Antigen Test Card
SEKISUI Diagnostics, LLC.: OSOM COVID-19 Antigen Home Test
Beijing Hotgen Biotech Co., Ltd.: Hotgen COVID-19 Antigen Home Test
CorDX, Inc.: CorDx COVID-19 Ag Test
Azure Biotech Inc.: Fastep COVID-19 Antigen Home Test
Oceanit Foundry LLC: ASSURE-100 Rapid COVID-19
Advin Biotech Inc.: Advin COVID-19 Antigen Test @Home
GenBody Inc.: GenBody COVID-19 Ag Home Test
Azure Biotech, Inc.: Azure FaStep COVID-19 Antigen Pen Home Test
Pfizer Inc.: Lucira by Pfizer COVID-19 & Flu Home Test
Princeton BioMeditech Corp: Status COVID-19 Antigen Rapid Test for Home Use
Nano-Ditech Corporation: Nano-Check COVID-19 Antigen At-Home Test
BioTeke USA, LLC: Bio-Self COVID-19 Antigen Home Test
3EO Health, Inc.: 3EO Health COVID-19 Test
Read the original here:
General Information About At-Home OTC COVID-19 Diagnostic Tests - FDA.gov