Ecotest® COVID-19 IgG/IgM CLIA Waived Rapid Antibody Test Device

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SKU:
COVID-224
Availability:
In stock
Shipping:
Calculated at Checkout

Bulk discount rates

Below are the available bulk discount rates for each individual item when you purchase a certain amount

Buy 10 - 19 and pay only $195.75 each
Buy 20 - 29 and pay only $180.00 each
Buy 30 or above and pay only $172.50 each
On Sale
  • POC COVID-19 IgG/IgM Rapid Test Device
  • POC COVID-19 IgG/IgM Rapid Test Device
On Sale: $175.00
Was: $205.00
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Description

COVID-19 Ecotest® Rapid Test Device is a lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2 in human venous whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary SARS-CoV-2 infections. The Ecotest® can detect antibodies 5-7 days after symptoms first appear. The results are reported in 15 mintues and are presented through visual representation of color development.

This test has not been FDA cleared or approved. 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Due to FDA Guidelines and supply chain demands all Coronavirus (COVID-19) related orders are non-returnable and non-refundable.

KEY FEATURES:

  • FDA Emergency Use Authorized (EUA)
  • Point-of-Care CLIA Waived
  • Helps aid in detecting prior infection of SARS-CoV-2
  • Rapid results in 10 minutes
  • Convenient, Disposable and Affordable

PRODUCT ATTACHMENTS:

CPT Code: 86328, Immunoassay for infectious agent antibody(ies), qualitative or semiqualitative, single-step method (eg, reagent strip).

Current Procedural Terminology (CPT®) codes have been created that streamline the novel coronavirus testing currently available in the United States market. Effective April 10, 2020, the code was established to report antibody testing performed using a single-step method immunoassay and will allow for tracking of COVID19 antibody testing. The test is performed using a strip that contains all of the critical components for testing from a blood or serum sample. According to AMA, Code 86328 should be reported once for each reagent strip assay. If a single strip tests for multiple antibody classes, only one unit of service should be reported. No reimbursement information is currently available for this code, but it should be available with no cost-sharing for Medicare beneficiaries. Other Providers may have different policies and it will be important to contact them regarding their specific policies.

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Additional Information

Classification:
FDA Emergency Use Authorized
Contents:
20 tests, 20 pipettes, 20 lancets, 20 alcohol prep pads, 1 buffer tube, 1 package insert
Country of Origin:
China
Professional Use Only:
These tests are available for medical healthcare professionals and are not intended for home use
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