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
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