CareStart™ COVID-19 Rapid Antigen Test Device

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SKU:
RCHM-02071
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 $300.00 each
Buy 20 - 29 and pay only $280.50 each
Buy 30 or above and pay only $250.00 each
On Sale
  • CareStart™ Point-of-Care COVID-19 Rapid Antigen Test Device
  • CareStart™ Point-of-Care COVID-19 Rapid Antigen Test Device
  • CareStart™ Point-of-Care COVID-19 Rapid Antigen Test Device
On Sale: $255.75
Was: $315.00
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Description

COVID-19 CareStart™ Antigen test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab specimens directly collected, or collected in BD universal transport media, from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high 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.

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)
  • Lateral flow assay producing rapid results in 10 minutes
  • Minimally invasive specimen collection (nasopharyngeal or anterior nasal)
  • Intended at Point-of-Care setting (i.e., in patient care settings) by medical professionals
  • Detect SARS-CoV-2 nucleocapsid protein antigen
  • Identify acute infection with 88.4% sensitivity and 100% specificity

PRODUCT ATTACHMENTS:

INSTRUCTIONS:

Test Instructions

Test Interpretation

 

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Additional Information

Classification:
FDA Emergency Use Authorized
Contents:
20 tests, 20 buffer vials, 20 nasal swabs, 1 positive control, 1 negative control, 1 package insert, 1 quick reference instructions
Country of Origin:
United States
Professional Use Only:
These tests are available for medical healthcare professionals and are not intended for home use
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