General Information About At-Home OTC COVID-19 Diagnostic Tests – FDA.gov

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

Alternate brand name:

ACON Laboratories, Inc: Flowflex COVID-19 Antigen Home Test

Alternate brand name:

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

Alternate brand name:

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

Alternate brand name:

PHASE Scientific International, Ltd.: INDICAID COVID-19 Rapid Antigen At-Home Test

Quidel Corporation: QuickVue At-Home OTC COVID-19 Test

Alternative Brand Names:

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

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General Information About At-Home OTC COVID-19 Diagnostic Tests - FDA.gov