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iHealth Labs, Inc.

iHealth COVID-19 Antigen Rapid Test, 2 tests/pack, FDA EUA approved OTC At-Home Rapid Antigen Self Test Share on WhatsApp

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Product & Manufacturer Details

Best for children, the iHealth COVID-19 Antigen Rapid Test offers testing for those as young as two in your household.

Indication:  Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.  

Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of the iHealth COVID-19 Antigen Rapid Test.

Specifications: 

90 Packs/Carton, 2 Tests/Pack

November 5, 2021, Letter FDA Emergency Use Authorization (EUA) for emergency use of the iHealth COVID-19 Antigen Rapid Test

EUA210470/S010:  Expiration with extended FDA EUA approval Feb. 2023 (*note extension granted 6 months beyond date printed on package Aug. 2022.

UPC #

856362005890
SKU # COV-AG-2-CTN
Model # ICO-3000
Packs Per Carton 90
Tests Per Pack 2
Single Package Dimensions (LxWxH) 6.18 × 3.19 × 0.71 Inches
Single Package Weight (lb) 0.13
Carton Dimension (LxWxH) 13.1 x 11.8 x 10.8 Inches

Carton Weight (lb)

12.8

COVID-19 Antigen Rapid Test

www.ihealthlabs.com

KEY FEATURES

  • FDA AUTHORIZED 15 MINS SELF-TEST  The test is a 15-minute self-test to detect nucleocapsid protein antigen from SARS-CoV-2. The test can be completed in the comfort of your own home without the need to ship your sample to a lab.
  • EASY TO USE ZERO DISCOMFORT Test can be done by inserting only 1/2 to 3/4 inch with a simple non-invasive nasal swab, easy to use, and zero discomfort. Step by step instructional videos are available in our app for easy following. (Installation of app is optional).
  • FOR AGES 2 AND ABOVE The self-administered test is recommended for individuals aged 15 years and older. Adult-collection is required for testing children 2-14 years old.
  • DETECT CURRENT AND NEW COVID VARIANTS iHealth has completed in-lab testing on several heat inactivated variant strains and the results show that iHealth COVID-19 Antigen Rapid Test was able to detect the mutations.
  • GROUP TESTING MANAGING VIA MOBILE APP The iHealth COVID-19 Test app allows the administrator of a small group to monitor and track the group members’ test results when needed at school, work or event.

This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected nasal swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom Onset. 

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