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Specification
Brand : Hotgen
BulletPoint1 : 【Expiration Date Extension】- On April 13, 2023, the FDA granted another four-month shelf-life extension for the Hotgen COVID-19 Antigen Rapid Test, which extended the shelf-life of all Hotgen tests from 6 months to 10 months. The production date and expiration date are shown on the back of the packaging box.
BulletPoint2 : 【FDA EUA Authorized COVID-19 Test Card】- Hotgen - COVID-19 Antigen Home Test is authorized under the Emergency Use Authorization (EUA) to detect whether an individual is infected with COVID-19. Easy to use. No need to send your sample to the lab.15 Min Rapid Test: 15-minute self-test. It can be performed anywhere at any time.
BulletPoint3 : 【Comfortable Self-test】- The test can be used by yourself without the need for professional sample collection. Gently nasal swab collect the sample, comfortable at-home self test. Self-testing recommended for people aged 14 and above. Children aged 2 to 14 years should be tested by an adult.
BulletPoint4 : 【Results Effective】- It detects both symptomatic and non-symptomatic COVID-19 infection. It is the safe choice of at-home OTC product.
BulletPoint5 : 【Suitable for All Events】- Easy to carry with convenient size. It is suitable for all events.
Color : Blue & White Packaging（test Kit）
ExternallyAssignedProductIdentifier : 6936700405224
FcShelfLife : 776.25 days
FdaDeviceClassification : ii
FdaIndicationOfUse : otc
FdaInstructionsForUseType : consumer
FdaLabelType : consumer
FdaPremarketApprovalNumber510k : EUA210610
FdaPremarketApprovalNumberPma : EUA210610
IsExpirationDatedProduct : 1
ItemForm : Liquid
ItemName : COVID-19 Antigen Home Test - 1 Pack, 10 Tests Total, FDA EUA Authorized OTC at-Home Self Test,COVID Self Test Results in 15 Mins with Nasal Swab No Discomfort
ItemPackageDimensions_Height : 17.399 centimeters
ItemPackageDimensions_Length : 9.1948 centimeters
ItemPackageDimensions_Width : 9.6012 centimeters
ItemTypeKeyword : professional-medical-clinical-diagnostic-test-kits
ItemVolume : 10 milliliters
Manufacturer : Beijing Hotgen Biotech Co., Ltd.
ModelName : HTK-20241106
NumberOfItems : 1
NumberOfPieces : 1
PartNumber : 6936700405224
ProductDescription :

Components Per Pack: SARS-CoV-2 Antigen Test Cassette, Sample Tube 0.5mL*1, and Disposable Sterile Swab*1

Sample type:Human anterior nasal (nares) swabs

Applicabie crowd:

Non-prescription home use with self-collected anterior nasal (nares) swab samples

For individuals aged 14 years or older

For individuals aged two years or older, please collect anterior nasal (nares) swab samples with assistance from adults

Within the first 7 days of Covid-19 symptoms onset

AWARNINGS

Do not use on anyone who is prone to nosebleeds or has had facial injuries or head injuries/surgery in the past six months.

Do not ingest any kit components.

Avoid exposure of your skin, eyes, nose, or mouth to the solution in thetube.

Use within 2 hours after opening the foil pouch.

Do not use on anyone under 2 years of age.

Required but not included in the test kit: a timer.

ProductExpirationType : Expiration On Package
ProductSiteLaunchDate : 2023-01-03T12:42:56.147Z
Size : 10ml Glass
SpecificUsesForProduct : H Pylori Test
SupplierDeclaredDgHzRegulation : not_applicable
SupplierDeclaredHasProductIdentifierExemption : 1
TestType : Array
UnitCount : 10
UnspscCode : 42312300