At-Home OTC COVID-19 Diagnostic Tests

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

• 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

Alternate brand name:

• 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

Alternate brand name:

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Alternate brand name:

• 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

• 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 

• 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

• 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

• 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

• 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

• 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

Alternate brand name:

• 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

• 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

• 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

Alternative Brand Names:

 

• 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

• 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

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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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