Access Bio, Antigen COVID-19 Test Kits

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