The rapid COVID-19 Antigen Test is FDA Emergency Use Authorized, CLIA Waived, and allows for an efficient, accurate, and cost-friendly method of detection at the Point-of-Care. In just 10 minutes, the test is able to detect the SARS-CoV-2 nucleocapsid protein antigen through visual interpretation of colored lines.The SARS-CoV-2 nucleocapsid protein antigen is generally detectable in nasopharyngeal swab specimens during the acute phase of infection. This test is intended for individuals suspected of COVID-19 within five days of symptom onset.

U.S.A. Manufactured Rapid Covid-19 Antigen Test Kit

Antigen test at Point of Care

Rapid 10-Minute Test Using Nasopharyngeal Swab

Authorized by FDA Under EUA

CLIA waved for Point of Care

Eligible for Medicare Reimbursement - Estimated $45.00 CLIA CPT 87811

COVID 19 Antigen Test Cassette & swab – 20 per box

All Sales are Final

$999.95 $899.95

U.S.A. Manufactured Rapid Covid-19 Antigen Test Kit

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Description

Coronavirus (SARS-CoV-2) Antigen – Rapid Test Cassette
(nasopharyngeal swab specimen)

    • 20 tests per box
    • FDA Emergency Use Authorization (EUA)
    • CLIA waiver for Point of Care Use
    • CE Declaration – Cleared for use in the European Union
    • Pharmacy/Pharmacist use authorized by the HHS
    • Easy to use, results in minutes

Additional information

Weight 15.5 oz
Dimensions 9 × 7 × 5 in
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Rapid Connect Medical
Product Disclaimer

By purchasing this product, customers are agreeing to the following terms and conditions:

1.FDA Regulations and Limitations of Use

In compliance with the US FDA Emergency Use Authorization (EUA) for the CareStart COVID-19 Antigen Test, this Agreement is to ensure your receipt, understanding, and compliance with the terms of this EUA. The full EUA CareStartCOVID-19 Antigen test can be found at the link here:

h ttps://www.fda.gov/media/142916/download

Although not limited to the following, we would like to clearly outline some notable points from this Emergency Use Authorization:

Authorized Laboratories

Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Additional Points

  • This test has not been FDA cleared or approved.
  • This test has been authorized by FDA under an EUA for use by authorized laboratories.
  • This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
  • Authorized laboratories using your product will use your product as outlined in the authorized
  •  
  • Deviations from the authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use your product are not permitted.
  • Authorized laboratories that receive your product will notify the relevant public health authorities of their intent to run your product prior to initiating testing.


ALL CRITERIA OUTLINED IN THE EMERGENCY USE AUTHORIZATION ARE APPLICABLE TO SALE, RESALE, AND USE OF THE CARESTART COVID-19 ANTIGEN TEST AND ARE NOT RESTRICTED TO ONLY THOSE NOTED ABOVE.

By purchasing this product, you, as a registered authority for your company, are acknowledging receipt and compliance to the terms outlined above. In purchasing this product, you and the company you are representing agree to indemnify and hold harmless BTNX Inc. and Rapid Connect Medical LLC from any and all fines, damages, losses, costs and expenses incurred as a result of any breach of this Agreement by yourself or any third party introduced to this the product by your company.

Additionally, when placing this order, the Customer acknowledges and agrees that they: (a) have read the foregoing disclaimer, (b) understand the limitations of Company’s liability, and (c) hereby indemnify and hold harmless the Company, its respective affiliates, owners, executives, members, managers, principals, officers, agents, employees, successors, and assigns against any and all claims, losses, damages, liabilities, penalties, punitive damages, expenses, reasonable legal fees and costs of any kind or amount whatsoever, which result from the negligence by the Purchaser, or its successors and assigns that occurs in connection with using the Products. This section remains in full force and effect even after the Company has delivered its Products to the Purchaser and the transaction is completed.