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Specification
Brand : ASSURE-100
BulletPoint1 : Spread Aloha, not COVID. Developed in Hawaii and made with proprietary, reliable technology used by doctors nationwide. Detects multiple COVID-19 variants, including Delta and Omicron
BulletPoint2 : FAST RESULTS: At home test with results for you or your family in 20 minutes. The test can be completed in the comfort of your own home without the need to ship your sample to a lab FDA Emergency Use Authorized Rapid COVID-19 Test: Authorized for personal, at-home use with an EUA from the U.S. FDA, granted in 2022: https://www.fda.gov/media/164168/download
BulletPoint3 : CONVENIENTLY TEST AT HOME: 2 nasal swab tests are included in each box, used to detect active infection, with or without symptoms
BulletPoint4 : FSA/HSA ELIGIBLE: Test may be reimbursed, depending on coverage; contact your health insurance company to learn more
BulletPoint5 : FOR AGES 2 TO ADULT: For children as young as 2 years old when administered by an adult, and for all people 14 and older to self-administer
Color : Cobalt Test Kit
ContainsLiquidContents : 1
ExternallyAssignedProductIdentifier : 00860011350200
ExternallyAssignedProductIdentifier1 : 768124439419
ExternallyAssignedProductIdentifier2 : 0768124439419
ExternallyAssignedProductIdentifier3 : 00717076044851
FcShelfLife : 900 days
FdaDeviceClassification : ii
FdaIndicationOfUse : otc
FdaInstructionsForUseType : consumer
FdaLabelType : consumer
IncludedComponents : Nasal swab, test casette, solution vial
IsExpirationDatedProduct : 1
ItemName : ASSURE-100 Rapid COVID-19 Test multipack, 6 Tests Total, FDA EUA Authorized OTC at-Home Self Test, Rapid Results with Non-invasive Nasal Swab, Easy to Use & No Discomfort
ItemPackageDimensions_Height : 20.0914 centimeters
ItemPackageDimensions_Length : 6.2992 centimeters
ItemPackageDimensions_Width : 7.6962 centimeters
ItemPackageQuantity : 3
ItemTypeKeyword : professional-medical-clinical-diagnostic-test-kits
LiquidVolume : 300 milliliters
Manufacturer : Oceanit Foundry
Material : Plastic
ModelNumber : AL8004
NumberOfBoxes : 1
NumberOfItems : 6
PackageLevel : unit
PartNumber : 531-102-3-6-0
ProductDescription : The ASSURE-100 Rapid COVID-19 Home Test from Oceanit can be used to detect active infection, with or without symptoms. The rapid-result test is for personal use. See results in 20 minutes. The pack includes 6 tests that are indicated for serial testing. Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with or without symptoms of COVID-19, within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. Legal Disclaimer The ASSURE-100 Rapid COVID-19 Home Test has not been FDA cleared or approved. It has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.
ProductExpirationType : Shelf Life
ProductSiteLaunchDate : 2023-12-14T05:10:45.071Z
Size : 2 Inch
StreetDate : 2018-09-04T00:00:01Z
Style : Compact
SupplierDeclaredDgHzRegulation : not_applicable
SupplierDeclaredDgHzRegulation1 : not_applicable
SupplierDeclaredDgHzRegulation2 : not_applicable
SupplierDeclaredDgHzRegulation3 : not_applicable
SupplierDeclaredDgHzRegulation4 : not_applicable
SupplierDeclaredDgHzRegulation5 : not_applicable
TemperatureRating : Ambient: 15 to 25 C (59 to 77 F)
UnitCount : 1