• This product has been authorized by the FDA under its Emergency Use Authorization
  • Customers should review requirements, including notification of public health authorities, as they are stated here: https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices

 

CareStart Covid-19 Antigen Rapid Test Kit

$475.00Price
    • Customers should review the Instructions For Use found here: https://www.fda.gov/media/142919/download
    • Customers should review the Fact Sheet for Providers found here: https://www.fda.gov/media/142917/download
    • Customers should make available to patients the Fact Sheet for Recipients found here: https://www.fda.gov/media/142918/download
    • Emergency use of this test is limited to authorized 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
    • Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status; Positive results do not rule out a bacterial infection or co-infection with other viruses
    • Negative results are presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed; negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
    • 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 nasopharyngeal swab specimens either directly collected or collected in BD universal transport media from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of symptom onset
    • Identify acute infection with 88.4% sensitivity and 100% specificity
    • Intended at POC setting (i.e., in patient care settings) by medical professionals with a CLIA waiver
  • Manufacturer # RCHM-02071
    Brand CareStart™
    Manufacturer Intrivo Diagnostics
    Country of Origin Unknown
    Application Rapid Test Kit
    Contents (20) Test Devices, (20) Assay Buffers, (20) Extraction Vials and Caps, (20) Specimen Collection Swabs, (1) Positive and (1) Negative Control Swab, Instructions for Use
    Number of Tests 20 Tests
    Reading Type Visual Read
    Sample Type Nasopharyngeal Swab Sample
    Storage Requirements USP Controlled Room Temperature
    Test Format Cassette
    Test Method Lateral Flow Immunochromatographic Assay
    Test Name Covid-19 Antigen
    Test Type Antigen Test
    Time to Results 10 Minute Results

Radiological Imaging Services, LLC  ©2020 All rights reserved. Do not copy any part of this site without permission.

Webmaster             Site Map 

THE SALE OF ITEMS ON THIS SITE MAY BE SUBJECT TO REGULATION BY THE U.S. FOOR AND DRUG ADMINISTRATION AND STATE AND LOCAL REGULATORY AGENCIES.

© 2019,2020,2021 Property of Radiological Imaging Services ,LLC