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Rapid Diagnostic Test for the Detection of SARS-CoV-2 Antigen

CareStart™ COVID-19 Antigen Test

US-made intended point-of-care (POC) test with results in minutes
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CareStart™ COVID-19 Antigen Test for

COVID-19

The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare providers.

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.

Made in the USA – intended Point-of-Care (POC) test with results in minutes!

CareStart™ COVID-19 Antigen Rapid Test Device Demonstration

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Purchasing Information

GPO+ MEMBERS

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Get Your FREE Membership Discount Instantly!

PLEASE NOTE THIS IS NOT FOR INDIVIDUAL PURCHASE OR USE. THIS IS STRICTLY FOR BUSINESSES AND GOVERNMENTAL ORGANIZATIONS.

Any orders shipped to a personal address or non-medical business address will be voided and refunded.

Product Information
FDA Annoucement
Authorized by

The U.S. Food and Drug Administration

“Authorizing point-of-care serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19,”

– FDA Commissioner Stephen M. Hahn, M.D.

CareStart™ COVID-19 Antigen Test Product Documents

Product Information + Instructions

fastep-covid-downloads-ifu

Instructions for Use: CareStart™ COVID-19 Antigen Test

Click to view or download

Rapid POC Antigen Test CareStart COVID-19 Antigen Test-2

Rapid POC Antigen Test: CareStart™ COVID-19 Antigen Test

Click to view or download

Product Profile CareStart™ COVID-19 Antigen Test

Product Overview: CareStart™ COVID-19 Antigen Rapid Tests

Click to view or download

Features CareStart™ Antigen Test

Features: CareStart™ COVID-19 Antigen Rapid Tests

Click to view or download

Authorization + Fact Sheets

FDA EAU Letter of Authorization

FDA EUA: Letter of Authorization

Click to view or download

Fact Sheet for Healthcare Providers

Healthcare Providers Fact Sheet

Click to view or download

Fact Sheet for Patients

Patients Fact Sheet

Click to view or download

CPT Coding/Reporting + Reimbursements

CPT Reporting for COVID-19 Testing

CPT Coding/Reporting for COVID-19 Testing

Click to view or download

United Healthcare COVID-19 Provider Billing Guidance

United Healthcare: COVID-19 Provider Billing Guidance

Click to view or download

Medicare Administrative Contractor Test Pricing

Medicare Administrative Contractor (MAC) Test Pricing

Click to view or download

CMS Reimbursement Ruling

CMS Reimbursement Ruling CMS-2020-01-R

Click to view or download

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