• KOTEX

Access Bio, Antigen COVID-19 Test Kits

Updated: Dec 8, 2020

CareSart COVID-19 Ag


FDA (U.S Food & Drug Administration) Emergency Use Authorization

CE Approved

Type: Antigen COVID-19 Diagnostic kits

Result: within 10 mins

Manufacturer/origin: USA


Due to the highly contagious nature and global health crisis, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO) and continues to have devastating impacts on healthcare systems and the world economy including the U.S. To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVID-19 cases is critical.

As an intended point-of-care (POC) designated test with a 10 minute processing time, CareStart™ COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.


  • Lateral flow assay

  • Rapid results in 10 minutes

  • Minimally invasive specimen collection (nasopharyngeal)

  • Intended at POC setting (i.e., in patient care settings) by medical professionals

  • Detect SARS-CoV-2 nucleocapsid protein antigen

  • Identify acute infection with high sensitivity and 100% specificity

  • FDA Approved


Purchasing or more information

chang@kotexsupplies.com


We are the authorized dealer for the Access Bio's COVID-19 Test kits.





Fact Sheet For Healthcare Providers

EUA-accessbio-CareSAntigen-hcp
.pdf
Download PDF • 171KB

Fact Sheet For Patients

EUA-accessbio-CareSAntigen-patient
.pdf
Download PDF • 157KB

IFU (Instructions for use)

EUA-accessbio-CareSAntigen-ifu
.pdf
Download PDF • 1.51MB

FDA EMERGENCY USE AUTHORIZATION

EUA202625_ABI-CareStart-COVID-19-Antigen
.
Download • 264KB

ACCESS BIO ANTIGEN PROFILE

201020 ANTIGEN PROFILE copy
.pdf
Download PDF • 16.77MB




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