Genabio Self-Test Kit, Rapid, Covid-19
2 tests
On This Page
Directions
Do Use: As an aid in the diagnosis of COVID-19. If you are concerned that you have been exposed to COVID-19. Do Not Use: On anyone under 2 years of age. If you are prone to nose bleeds. If you have had a facial or head injury/surgery in the last 6 months. Store at 2-30 degrees C.
Product Details
2 x COVID-19 test cards, 2 x swabs, 2 x pre filled tubes, 1 x instruction for use. Emergency use authorization. FDA. At home result in 15 mins. The Genabio COVID-19 Rapid Self-Test Kit is a lateral flow chromatographic immunoassay method intended for the qualitative detection of the nucleocapsid protein antigen from SARS-cov-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19. For in vitro diagnostic use. For use under the 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. You can use a single test, if you have any symptoms of COVID-19. If you do not have symptoms of COVID-19, you will need at least two tests per person. 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.; This product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (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. In Vitro diagnostic medical device. Email: info(at)genabio.com. Tel: 1-800-614-3365. Made in China.Nutrition Facts
Warnings
Do not re-use. Consult instructions for use.Manufacturer
Genabio Diagnostics Inc.
19 B Crosby Dr. Ste 220 Bedford, MA 01730 USA
UPC
00196852953004