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
|
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: 15 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
|
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: 18 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
| | - 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: 12 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
| | - 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: 17 months
|
ACON Laboratories, Inc.: Flowflex Plus COVID-19 and Flu A/B 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).
| - 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: 15 months
|