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Genabio

Genabio Covid-19 Rapid Self-Test

2 ct
$14.34 each

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Description

Emergency use authorization. FDA.
• 2X COVID-19 test cards; 2X swabs; 2X pre filled tubes. 1x instruction for use.
• At home result in 15 mins.
• The Genabio covid-19 rapid self test kit is a lateral flow chromatographic immunoassay device intended for the qualitative detection of the nucleocapsid protein antigen from sars-cov-2 in anterior nasal swab specimens directly from individuals with or without symptoms or other epidemiological reasons to suspect covid-19.
For in vitro diagnostic use.
• For emergency use authorization (eua) only.
• For ages 2 through 13, an adult Must collect and test the anterior nares specimen.
• This test does not determine if you had covid-19 in the past or if you have immunity.; for symptomatic individuals, the test is for serial testing at least twice over three days with at least 48 hours between tests.; for asymptomatic individuals, the test is for serial testing at least three times over five days with at least 48 hours between tests.
• You may need to purchase additional tests to perform serial (repeat) testing.
• This test is more likely to give you a false negative result when you have covid-19 than a lab-based molecular test.
• Determining a negative result requires multiple tests.
• In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an eua. 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. Made in China.