At-Home OTC COVID-19 Diagnostic Tests

At-Home OTC COVID-19 Diagnostic Tests

Abbott Diagnostics Scarborough, Inc.:
BinaxNOW COVID-19 Ag Card Home Test

Packaging for Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Ag Card Home Test

  • People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 15 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Requires supervision of a telehealth proctor and a smartphone or computer
  • Results in 15 minutes
  • Shelf Life: 22 months

Abbott Diagnostics Scarborough, Inc.:
BinaxNOW COVID-19 Antigen Self Test

Packaging for Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Antigen Self Test

  • People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 15 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15 minutes
  • Shelf Life: 22 months

Access Bio, Inc.:
CareStart COVID-19 Antigen Home Test

Packaging for Access Bio, Inc.: CareStart COVID-19 Antigen Home Test

Alternate brand name:

Packaging for On/go COVID-19 Antigen Self-Test

  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Smartphone optional
  • Alternate brand name: On/go COVID-19 Antigen Self-Test
  • Results in 10 minutes
  • Shelf Life: 21 months

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

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

Alternate brand name:

Packaging for On/Go One COVID-19 Antigen Home Test

  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Smartphone optional
  • Alternate brand name: On/Go One COVID-19 Antigen Home Test
  • Results in 15 minutes
  • Shelf Life: 24 months

Aptitude Medical Systems Inc.:
Metrix COVID-19 Test

Aptitude Medical Systems Inc.: Metrix COVID-19 Test package thumbnail

  • People with or without symptoms
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Molecular test
  • Nasal swab
  • Saliva
  • Requires a Metrix Reader (sold separately)
  • Smartphone optional
  • Results in 30 minutes
  • Shelf Life: 18 Months

Celltrion USA, Inc.:
Celltrion DiaTrust COVID-19 Ag Home Test

Packaging for Celltrion USA, Inc.: Celltrion DiaTrust COVID-19 Ag Home Test

  • People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Antigen test
  • Mid-turbinate nasal swab
  • Smartphone optional
  • Results in 15 minutes
  • Shelf Life: 24 months

CorDx, Inc.
CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test

Box for CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test

  • People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult 
  • Antigen test
  • Nasal swab
  • Results in 10 minutes
  • Shelf Life: 12 months

CTK Biotech, Inc.: 
ImmuView COVID-19 Antigen Home Test

ImmuView COVID-19 Antigen Home Test - Instructions for Use (Home Test)

  • People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15-30 minutes
  • Shelf Life: 20 months

Cue Health Inc.:
Cue COVID-19 Test for Home and Over The Counter (OTC) Use

Packaging for Cue Health Inc.: Cue COVID-19 Test for Home and Over The Counter (OTC) Use

  • Expiration Date: See box label
  • People with or without symptoms
  • Age 18 years and older
  • Age 2 years and older when collected by an adult
  • Molecular test
  • Nasal swab
  • Requires a Cue Cartridge Reader (sold separately)
  • Requires a smartphone
  • Results in 20 minutes
  • Shelf Life: 4 months

Ellume Limited:
Ellume COVID-19 Home Test

Packaging for Ellume Limited: Ellume COVID-19 Home Test

  • Expiration Date: See box label
  • People with symptoms that began within the last 4 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 16 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Mid-turbinate nasal swab
  • Requires a Smartphone
  • Results in 15 minutes
  • Shelf Life: 12 months

Genabio Diagnostics Inc.:
Genabio COVID-19 Rapid Self-Test Kit

Packaging for Genabio Diagnostics Inc.: Genabio COVID-19 Rapid Self-Test Kit

  • Expiration Date: See box label
  • People with symptoms that began within the last 7 days.
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15-30 minutes
  • Shelf Life: 18 months

iHealth Labs, Inc.:
iHealth COVID-19 Antigen Rapid Test

Packaging for iHealth Labs, Inc.: iHealth COVID-19 Antigen Rapid Test

Alternate brand name:

Packaging for GoodToKnow COVID-19 Antigen Rapid Test

  • People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 15 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Smartphone optional
  • Results in 15 minutes
  • Alternate brand name: GoodToKnow COVID-19 Antigen Rapid Test
  • Alternate brand name: GoToKnow COVID-19 Antigen Rapid Test
  • Shelf Life: 15 months

InBios International Inc:
SCoV-2 Ag Detect Rapid Self-Test

Packaging for InBios International Inc: SCoV-2 Ag Detect Rapid Self-Test

  • People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 20 minutes
  • Shelf Life: 13 months

Immunostics Inc.: Swab-N-Go Home Test COVID-19 Ag 

Box Label:  Immunostics Inc.: Swab-N-Go Home Test COVID-19 Ag

  • Expiration Date: See box label 
  • People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15-30 minutes 
  • Shelf Life: 20 months 

Pfizer Inc:
Lucira CHECK-IT COVID-19 Test Kit

Pfizer Check Box Label

  • People with or without symptoms
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Molecular test
  • Nasal swab
  • Smartphone optional
  • Results in 30 minutes
  • Shelf Life: 18 months

Maxim Biomedical, Inc.:
MaximBio ClearDetect COVID-19 Antigen Home Test

Packaging for Maxim Biomedical, Inc.: MaximBio ClearDetect COVID-19 Antigen Home Test

  • People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15 minutes
  • Shelf Life: 24 months

Mologic, Inc.:
COVI-Go SARS-CoV-2 Ag Self-Test

Mologic, Inc.: COVI-Go SARS-CoV-2 Ag Self-Test Box Label

  • Expiration Date: See box label
  • People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 20 minutes
  • Shelf Life: 6 months

OraSure Technologies, Inc.:
InteliSwab COVID-19 Rapid Test

Packaging for OraSure Technologies, Inc.: InteliSwab COVID-19 Rapid Test

  • People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 18 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Smartphone optional
  • Results in 30 minutes
  • Shelf Life: 24 months

OSANG LLC:
OHC COVID-19 Antigen Self Test

OHC COVID-19 Antigen Self Test Packaging

Alternate brand name:

Quickfinder Covid-19 Antigen Self Test Packaging

  • People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Alternate brand name: QuickFinder COVID-19 Antigen Self Test
  • Results in 15 minutes
  • Shelf Life: 24 months

OSANG LLC:
QuickFinder COVID-19/Flu Antigen Self Test

QuickFinder COVID-19/Flu Antigen Self Test Packaging

  • People with symptoms that began within the last 4 days. The test is to be performed two times over three days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult 
  • Antigen test
  • Nasal swab
  • Results in 15 minutes
  • Shelf Life: 12 months

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

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

  • People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 20 minutes
  • Shelf Life: 15 months

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

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

Alternative Brand Names:

CVS Health At Home COVID-19 Test Kit

 

Walgreens At-Home COVID-19 Test Kit

  • People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Alternative Brand Names: CVS Health At Home COVID-19 Test Kit and Walgreens At-Home COVID-19 Test Ket
  • Results in 10 minutes
  • Shelf Life: 16 months

Watmind USA: Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test

Box Label of the Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test

  • Expiration Date: See box label
  • People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15 minutes
  • Shelf Life: 18 months

SD Biosensor, Inc.:
Pilot COVID-19 At-Home Test

Packaging for SD Biosensor, Inc.: Pilot COVID-19 At-Home Test

FDA Safety Communication – Recall of Certain Lots

  • People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 20 minutes
  • Telehealth Proctor Supervised (optional)
  • Shelf Life: 16 months

Siemens Healthineers:
CLINITEST Rapid COVID-19 Antigen Self-Test

Packaging for Siemens Healthineer: CLINITEST Rapid COVID-19 Antigen Self-Test

  • People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15 minutes
  • Smartphone/Web access (optional)
  • Shelf Life: 24 months

Watmind USA:
Speedy Swab Rapid COVID-19 Antigen Self-Test

Packaging for Watmind USA: Speedy Swab Rapid COVID-19 Antigen Self-Test

  • People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing)
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15 minutes
  • Shelf Life: 21 months

Xiamen Boson Biotech Co., Ltd.:
Rapid SARS-CoV-2 Antigen Test Card

Packaging for Xiamen Boson Biotech Co., Ltd.: Rapid SARS-CoV-2 Antigen Test Card

  • People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15 minutes
  • Shelf Life: 18 months

SEKISUI Diagnostics, LLC.:
OSOM COVID-19 Antigen Home Test

OSOM COVID-19 Antigen Home Test - box label

  • Expiration Date: See box label
  • People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15-30 minutes
  • Shelf Life: 11 months

Beijing Hotgen Biotech Co., Ltd.:
Hotgen COVID-19 Antigen Home Test

Packaging for Hotgen COVID-19 Antigen Home Test

  • People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15-30 minutes
  • Shelf Life: 10 months

CorDX, Inc.:
CorDx COVID-19 Ag Test

Packaging for Axteria BioMed Consulting Inc.: CorDx COVID-19 Ag Test

  • Expiration Date: See box label
  • People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult 
  • Antigen test
  • Nasal swab
  • Results in 10-30 minutes
  • Shelf Life: 15 months

Azure Biotech Inc.:
Fastep COVID-19 Antigen Home Test

Packaging for Azure Biotech Inc.: Fastep COVID-19 Antigen Home Test

  • Expiration Date: See box label
  • People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15-30 minutes
  • Shelf Life: 24 months

Oceanit Foundry LLC:
ASSURE-100 Rapid COVID-19

Photo of Oceanit Assure Covid Test Box

  • Expiration Date: See box label
  • People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 20-30 minutes
  • Shelf Life: 12 months

Advin Biotech Inc.:
Advin COVID-19 Antigen Test @Home

Photo of AdvinBio_Covid16 Test box

  • People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15-30 minutes
  • Shelf Life:  24 months

GenBody Inc.:
GenBody COVID-19 Ag Home Test

Image of the GenBody COVID-19 Ag Home Test

  • Expiration Date: See box label
  • People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15-20 minutes
  • Shelf Life: 24 months

Azure Biotech, Inc.:
Azure FaStep® COVID-19 Antigen Pen Home Test

Azure FaStep® COVID-19 Antigen Pen Home Test Box Label

  • Expiration Date: See box label
  • People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult 
  • Antigen test
  • Nasal swab
  • Results in 15-30 minutes
  • Shelf Life: 21 months

Pfizer Inc.:
Lucira by Pfizer COVID-19 & Flu Home Test

Lucira COVID-19 & Flu Home Test - Box Label

  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Molecular test
  • Nasal swab
  • Results in 30 minutes
  • Shelf Life: 18 months

Princeton BioMeditech Corp:
Status COVID-19 Antigen Rapid Test for Home Use

Princeton Status COVID-19 Antigen

  • Expiration Date: See box label
  • People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15 minutes
  • Shelf Life: 24 months

Nano-Ditech Corporation:
Nano-Check COVID-19 Antigen At-Home Test

Packaging illustration

  • Expiration Date: See box label 
  • People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult 
  • Antigen test
  • Nasal swab
  • Results in 15 minutes 
  • Shelf Life: 6 months 

BioTeke USA, LLC:
Bio-Self COVID-19 Antigen Home Test

Packaging for Bio-Self COVID-19 Antigen Home Test

  • Expiration Date: See box label
  • People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed three times over five days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15-30 minutes
  • Shelf Life: 12 months

3EO Health, Inc.:
3EO Health COVID-19 Test

Packaging for 3EO Health COVID-19 Test

  • Expiration Date: See box label
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Molecular test
  • Nasal swab
  • Results in 30 minutes
  • Shelf Life: 4 months

SEKISUI Diagnostics, LLC:
OSOM Flu SARS-CoV-2 Combo Home Test

Packaging for SEKISUI Diagnostics, LLC: OSOM Flu SARS-CoV-2 Combo Home Test

  • Expiration Date: See box label
  • People with symptoms that began within the last 4 days. The test is to be performed two times over three days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 10-30 minutes
  • Shelf Life: 6 months

Wondfo USA Co., Ltd.
WELLlife COVID-19 / Influenza A&B Home Test

EUA-WELLLife Flu COVID OTC Box Label

  • Expiration Date: See box label
  • People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 10 minutes
  • Shelf Life: 6 months

iHealth Labs, Inc.:
iHealth COVID-19/Flu A&B Rapid Test

iHealth Labs, Inc.: iHealth COVID-19/Flu A&B Rapid Test Product labeling

  • Expiration Date: See box label
  • People with symptoms that began within the last 4 days. The test is to be performed two times over three days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15 minutes
  • Shelf Life: 14 months

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