At-Home OTC COVID-19 Diagnostic Tests (2024)

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

  • Extended Expiration Date
  • 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

  • Extended Expiration Date
  • 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:

  • Extended Expiration Date
  • 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:

  • Extended Expiration Date
  • 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

  • Extended Expiration Date
  • 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

  • Extended Expiration Date
  • 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
  • Antigen test
  • Mid-turbinate nasal swab
  • Smartphone optional
  • Results in 15 minutes
  • Shelf Life: 24 months

CorDx, Inc.

At-Home OTC COVID-19 Diagnostic Tests (9)

  • Extended Expiration Date
  • 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

At-Home OTC COVID-19 Diagnostic Tests (10)

  • Extended Expiration Date
  • 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:

  • Extended Expiration Date
  • 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

  • Extended Expiration Date
  • 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

At-Home OTC COVID-19 Diagnostic Tests (17)

  • 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

PfizerInc:
Lucira CHECK-IT COVID-19 Test Kit

At-Home OTC COVID-19 Diagnostic Tests (18)

  • Extended Expiration Date
  • 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

  • Extended Expiration Date
  • 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

  • Extended Expiration Date
  • 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: 24months

OSANG LLC:
OHC COVID-19 Antigen Self Test

Alternate brand name:

  • Extended Expiration Date
  • 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: 24months

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

At-Home OTC COVID-19 Diagnostic Tests (24)

  • 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: 12 months

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

  • Extended Expiration Date
  • 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:

At-Home OTC COVID-19 Diagnostic Tests (27)

At-Home OTC COVID-19 Diagnostic Tests (28)

  • Extended Expiration Date
  • 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:

At-Home OTC COVID-19 Diagnostic Tests (29)

  • 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 1

FDA Safety Communication - Recall of Certain Lots

  • Extended Expiration Date
  • 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: 16months

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

  • Extended Expiration Date
  • 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

  • Extended Expiration Date
  • 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

  • Extended Expiration Date
  • 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: 18months

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

At-Home OTC COVID-19 Diagnostic Tests (34)

  • 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

  • Extended Expiration Date
  • 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

At-Home OTC COVID-19 Diagnostic Tests (38)

  • 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

At-Home OTC COVID-19 Diagnostic Tests (39)

  • Extended Expiration Date
  • 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: 18months

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 FaStepยฎ 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.:

  • Extended Expiration Date
  • People with symptoms
  • 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: 18months

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: 12months

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

At-Home OTC COVID-19 Diagnostic Tests (46)

  • Expiration Date: See box label
  • People with symptoms.
  • 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

At-Home OTC COVID-19 Diagnostic Tests (47)

  • 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.

At-Home OTC COVID-19 Diagnostic Tests (48)

  • 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

iHealth Labs, Inc.:

At-Home OTC COVID-19 Diagnostic Tests (49)

  • 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
At-Home OTC COVID-19 Diagnostic Tests (2024)
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