CMS issues guidance ensuring Americans with health insurance have coverage for IgM/IgG antibody testing performed by their physician at no cost! Here is the policy.

PreventCare Presents the FDA Authorized Novel Coronavirus IgM/IgG Antibodies Test Kit For Healthcare Professionals

See the Emergency Use Authorization Documents below:​

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FDA Letter of Authorization

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NCI Report

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Fact Sheet for Healthcare Providers

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Fact Sheet for Healthcare Recipients

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Instruction for Use

FDA reviewed and authorized

Results in 15 minutes

No laboratory equipment necessary 

EC DECLARATION OF CONFORMITY: 

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The FaStep Antibody Test Kit, granted an Emergency Use Authorization by the FDA on July 6, 2020, brings a rapid solution to inform you about the presence of antibodies created in response to exposure to the novel coronavirus, and ease the burden on emergency healthcare services around the country. ​ 

​Clinical integrity is our foremost priority at PreventCare. These antibody test kits are designed and manufactured by Assure Tech, with nearly eight years of history with the FDA bringing products to the US market for both point-of-care and over the counter use. To date, Assure Tech has successfully earned 71 approvals for lateral flow chromatographic immunoassays and other products. 

This antibody kit has been internally validated by the manufacturer and by PreventCare. Please find the results of all non-FDA clinical studies performed on the FaStep device below: ​

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Manufacturer Validation study

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PreventCare Validation Study

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GCIR Validation Study

Utilize FaStep COVID-19 Antibody Test Kit to identify patients that carry SARS/COV-2 antibodies as the quarantines requirements begin to loosen around the country

See the approvals, FDA manufacturer registration and validation studies

Answers to your questions about administering the corona virus COVID-19 Antibody Test

Contact Us

Your questions and comments are very important to us. Please use this form to contact us and we will respond in a time-sensitive manner!

Address: 3725 Southeast Ocean Boulevard, Stuart, FL, USA

Phone Number: 844-954-2444

FDA Policy for COVID-19 Diagnostic Tests during the Public Health Emergency. Here is the policy.

 

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