Abbott Diagnostics Scarborough, Inc.:
BinaxNOW COVID-19 Ag Card Home Test
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- 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).
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- Age 15 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Requires supervision of a telehealth proctor and a smartphone or computer
- Results in 15 minutes
- Shelf Life: 22 months
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Abbott Diagnostics Scarborough, Inc.:
BinaxNOW COVID-19 Antigen Self Test
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- 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).
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- Age 15 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15 minutes
- Shelf Life: 22 months
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Access Bio, Inc.:
CareStart COVID-19 Antigen Home Test
Alternate brand name:
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- 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)
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Smartphone optional
- Alternate brand name: On/go COVID-19 Antigen Self-Test
- Results in 10 minutes
- Shelf Life: 21 months
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ACON Laboratories, Inc:
Flowflex COVID-19 Antigen Home Test
Alternate brand name:
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- 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)
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- 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
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Aptitude Medical Systems Inc.:
Metrix COVID-19 Test
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- People with or without symptoms
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Molecular test
- Nasal swab
- Saliva
- Requires a Metrix Reader (sold separately)
- Smartphone optional
- Results in 30 minutes
- Shelf Life: 18 Months
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CorDx, Inc.
CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test
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- People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 10 minutes
- Shelf Life: 15 months
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CTK Biotech, Inc.:
ImmuView COVID-19 Antigen Home Test
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15-30 minutes
- Shelf Life: 20 months
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Cue Health Inc.:
Cue COVID-19 Test for Home and Over The Counter (OTC) Use
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- Expiration Date: See box label
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- People with or without symptoms
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- Age 18 years and older
- Age 2 years and older when collected by an adult
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- Molecular test
- Nasal swab
- Requires a Cue Cartridge Reader (sold separately)
- Requires a smartphone
- Results in 20 minutes
- Shelf Life: 4 months
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Ellume Limited:
Ellume COVID-19 Home Test
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- Expiration Date: See box label
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- 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).
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- Age 16 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Mid-turbinate nasal swab
- Requires a Smartphone
- Results in 15 minutes
- Shelf Life: 12 months
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Genabio Diagnostics Inc.:
Genabio COVID-19 Rapid Self-Test Kit
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- Expiration Date: See box label
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- 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)
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15-30 minutes
- Shelf Life: 18 months
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iHealth Labs, Inc.:
iHealth COVID-19 Antigen Rapid Test
Alternate brand name:
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- 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).
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- Age 15 years and older
- Age 2 years and older when collected by an adult
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- 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
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InBios International Inc:
SCoV-2 Ag Detect Rapid Self-Test
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 20 minutes
- Shelf Life: 13 months
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Immunostics Inc.: Swab-N-Go Home Test COVID-19 Ag
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- Expiration Date: See box label
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15-30 minutes
- Shelf Life: 20 months
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Pfizer Inc:
Lucira CHECK-IT COVID-19 Test Kit
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- People with or without symptoms
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Molecular test
- Nasal swab
- Smartphone optional
- Results in 30 minutes
- Shelf Life: 18 months
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Maxim Biomedical, Inc.:
MaximBio ClearDetect COVID-19 Antigen Home Test
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15 minutes
- Shelf Life: 24 months
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Mologic, Inc.:
COVI-Go SARS-CoV-2 Ag Self-Test
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- Expiration Date: See box label
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 20 minutes
- Shelf Life: 6 months
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OraSure Technologies, Inc.:
InteliSwab COVID-19 Rapid Test
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- 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).
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- Age 18 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Smartphone optional
- Results in 30 minutes
- Shelf Life: 24 months
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OSANG LLC:
OHC COVID-19 Antigen Self Test
Alternate brand name:
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- 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)
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Alternate brand name: QuickFinder COVID-19 Antigen Self Test
- Results in 15 minutes
- Shelf Life: 24 months
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OSANG LLC:
QuickFinder COVID-19/Flu Antigen Self Test
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- People with symptoms that began within the last 4 days. The test is to be performed two times over three days (serial testing).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15 minutes
- Shelf Life: 12 months
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PHASE Scientific International, Ltd.:
INDICAID COVID-19 Rapid Antigen At-Home Test
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 20 minutes
- Shelf Life: 15 months
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Quidel Corporation:
QuickVue At-Home OTC COVID-19 Test
Alternative Brand Names:
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- 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
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Watmind USA: Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test
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- Expiration Date: See box label
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- People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15 minutes
- Shelf Life: 18 months
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SD Biosensor, Inc.:
Pilot COVID-19 At-Home Test
FDA Safety Communication - Recall of Certain Lots
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 20 minutes
- Telehealth Proctor Supervised (optional)
- Shelf Life: 16 months
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Siemens Healthineers:
CLINITEST Rapid COVID-19 Antigen Self-Test
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15 minutes
- Smartphone/Web access (optional)
- Shelf Life: 24 months
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Watmind USA:
Speedy Swab Rapid COVID-19 Antigen Self-Test
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15 minutes
- Shelf Life: 21 months
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Xiamen Boson Biotech Co., Ltd.:
Rapid SARS-CoV-2 Antigen Test Card
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15 minutes
- Shelf Life: 18 months
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SEKISUI Diagnostics, LLC.:
OSOM COVID-19 Antigen Home Test
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- Expiration Date: See box label
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15-30 minutes
- Shelf Life: 11 months
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Beijing Hotgen Biotech Co., Ltd.:
Hotgen COVID-19 Antigen Home Test
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15-30 minutes
- Shelf Life: 10 months
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CorDX, Inc.:
CorDx COVID-19 Ag Test
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- Expiration Date: See box label
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 10-30 minutes
- Shelf Life: 15 months
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Azure Biotech Inc.:
Fastep COVID-19 Antigen Home Test
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- Expiration Date: See box label
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15-30 minutes
- Shelf Life: 24 months
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Oceanit Foundry LLC:
ASSURE-100 Rapid COVID-19
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- Expiration Date: See box label
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 20-30 minutes
- Shelf Life: 12 months
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Advin Biotech Inc.:
Advin COVID-19 Antigen Test @Home
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15-30 minutes
- Shelf Life: 24 months
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GenBody Inc.:
GenBody COVID-19 Ag Home Test
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- Expiration Date: See box label
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15-20 minutes
- Shelf Life: 24 months
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Azure Biotech, Inc.:
Azure FaStep® COVID-19 Antigen Pen Home Test
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- Expiration Date: See box label
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15-30 minutes
- Shelf Life: 21 months
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Pfizer Inc.:
Lucira by Pfizer COVID-19 & Flu Home Test
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Molecular test
- Nasal swab
- Results in 30 minutes
- Shelf Life: 18 months
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Princeton BioMeditech Corp:
Status COVID-19 Antigen Rapid Test for Home Use
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- Expiration Date: See box label
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15 minutes
- Shelf Life: 24 months
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Nano-Ditech Corporation:
Nano-Check COVID-19 Antigen At-Home Test
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- Expiration Date: See box label
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- 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).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15 minutes
- Shelf Life: 6 months
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BioTeke USA, LLC:
Bio-Self COVID-19 Antigen Home Test
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- Expiration Date: See box label
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- 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)
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15-30 minutes
- Shelf Life: 12 months
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3EO Health, Inc.:
3EO Health COVID-19 Test
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- Expiration Date: See box label
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Molecular test
- Nasal swab
- Results in 30 minutes
- Shelf Life: 4 months
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SEKISUI Diagnostics, LLC:
OSOM Flu SARS-CoV-2 Combo Home Test
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- People with symptoms that began within the last 4 days. The test is to be performed two times over three days (serial testing).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 10-30 minutes
- Shelf Life: 12 months
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Wondfo USA Co., Ltd.
WELLlife COVID-19 / Influenza A&B Home Test
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- Expiration Date: See box label
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- People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 10 minutes
- Shelf Life: 6 months
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iHealth Labs, Inc.:
iHealth COVID-19/Flu A&B Rapid Test
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- Expiration Date: See box label
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- People with symptoms that began within the last 4 days. The test is to be performed two times over three days (serial testing).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15 minutes
- Shelf Life: 14 months
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ACON Laboratories, Inc.:
Flowflex Plus COVID-19 and Flu A/B Home Test
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- Expiration Date: See box label
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- People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).
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- Age 14 years and older
- Age 2 years and older when collected by an adult
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- Antigen test
- Nasal swab
- Results in 15 minutes
- Shelf Life: 15 months
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