Access Bio, Antibody COVID-19, Corona Test Kits

CareSart COVID-19 IgM/IgG

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

Type: Antibody COVID-19 Diagnostic kits

Result: within 10 mins

Manufacturer/origin: USA

SARS-CoV-2, A highly contagious novel virus, had severely impacted the U.S. and global healthcare system and economy. A rapid in vitro testing is a key component to identify and mitigate the spread. The CareStart™ Covid 19 IgM/IgG Rapid Diagnostic Test for the Detection of SARS-CoV-2 IgM/IgG Ab provides a fast and easy diagnostic tool for COVID-19 in the limited testing environment.

• Fast and easy to use in a qualified CLIA setting

• Detect and differentiate IgM/IgG antibody specific to SARS-CoV-2.

• Requires small sample volume (10 uL of venous whole blood, serum, or plasma).

• Results available in 10 minutes.

• No equipment or training required.

• Identify and monitor individual’s previous infection history and immune response to COVID-19.

• Clinical performance (NIH/NCI) of 100% sensitivity and 97.5% specificity.

• FDA and CE certified.

Purchasing or more information

chang@kotexsupplies.com

Fact Sheet For Healthcare Providers

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Fact Sheet For Patients

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IFU (Instructions for use)

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FDA EMERGENCY USE AUTHORIZATION

EUA201309-Access-Bio-Letter-of-Authoriza

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Download Brochures

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