CareStart- COVID-19 Antigen Home Test (TK-7) ‚ÄĒ VizoCare Skip to content
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Self Test for SARS-CoV-2 Antigen Detection


The¬† CareStart‚ĄĘ¬†COVID-19 Antigen Home Test is a¬†lateral flow immunoassay intended for the¬†qualitative detection of nucleocapsid protein¬†antigens from SARS-CoV-2.

Under FDA's EUA,¬†CareStart‚ĄĘ COVID-19 Antigen Home Test is¬†authorized for non-prescription home use with¬†self-collected anterior nasal {nares) swab samples¬†from individuals aged 14 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 {nares) swab samples from individuals aged 2 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 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 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours {and no more than 48 hours) between tests.

  • For use under Emergency Use Authorization Only
  • For¬†In Vitro¬†Diagnostic Use Only

Features

  • Fast and easy to self-test at anywhere
  • Easy to interpret the results using mobile application
  • Qualitatively detect the SARS-CoV-2 nucleocapsid protein
  • Use for nasal swab specimen
  • Fast results only in 10 minutes
  • Identify individual‚Äôs current infection status to COVID-19

Compatible OS Systems:

  • iOS13 or newer for Apple iPhone
  • Android10 or newer for Android Phone

Disclaimer:

  • As of November 22, 2021,¬†CareStart‚ĄĘ COVID-19 Antigen Home Test is authorized to use with individual anterior nasal swab specimens from individuals aged 14 years and older (self-collected), or 2 years and older (collected with adult assistance) for non-prescription home use by FDA under the EUA (EUA210314/S002). The authorized labeling has been changed with the new indication (Quick Reference Instructions (QRI) and Fact Sheet for Individuals,¬†Instructions for Use (IFU) for Healthcare Providers (HCP),¬†¬†Fact Sheet for HCP, and¬†¬†kit package); however,¬†CareStart‚ĄĘ COVID-19 Antigen Home Test will continue to be distributed with the labeling previously authorized per EUA210314/S001 on the FDA‚Äôs enforcement discretion in efforts to increase the testing accessibility for COVID-19. Since the differences between the¬†CareStart‚ĄĘ COVID-19 Antigen Home Test kit previously authorized (EUA210314/S001) and currently authorized (EUA210314/S002) are limited to the authorized labeling, you may use the¬†CareStart‚ĄĘ COVID-19 Antigen Home Test kit with the new indication for use (described above).

Order Information

CATALOG NO. RCPM-00171, RCPM-00271, RCPM-00471, and RCPM-02071

PACKAGE UNIT: 2 Test /Kit

KIT COMPONENT: 
  • Test Devices
  • Extraction Vials and Caps
  • Nasal Swab
  • User Instructions with Fact Sheet for Individuals

Procedure

 

 

 

 

 

 

 

 

 

 

 

Results Interpretation



FACT SHEET FOR HEALTHCARE PROVIDERS

INSTRUCTIONS FOR USE HEALTHCARE

FDA EMERGENCY USE AUTHORIZATION

USER INSTRUCTIONS AND FACT SHEET