At-Home OTC COVID-19 Diagnostic Tests

Ella Castle

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 […]

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
  • Expiration Date: See 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
  • Saliva
  • Requires a Metrix Reader (sold separately)
  • Smartphone optional
  • Results in 30 minutes
  • Shelf Life: 12 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

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

ImmuView COVID-19 Antigen Home Test - Instructions for Use (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: 12 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

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

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: 18 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
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