Home / Clinical Laboratory / Test Kits / Rapid Test Kit / Rapid Test Kit RightSign™ Antibody Test COVID-19 IgG / IgM Whole Blood / Serum / Plasma Sample 20 TestsRT-CV19-20
Picture of Rapid Test Kit RightSign™ Antibody Test COVID-19 IgG / IgM Whole Blood / Serum / Plasma Sample 20 TestsRT-CV19-20

Rapid Test Kit RightSign™ Antibody Test COVID-19 IgG / IgM Whole Blood / Serum / Plasma Sample 20 TestsRT-CV19-20

Rapid-Test-Kit-RightSign™-Antibody-Test-COVID-19-IgG--IgM-Whole-Blood--Serum--Plasma-Sample-20-TestsRT-CV19-20

SKU #

#1163497

MPN #

RT-CV19-20

Brand

Premier Biotech

Stock

In Stock

Quantity

100

Features

TEST KIT, COVID-19 IGG/IGM WHOLE BLD/SERUM PLASMA

$142.37 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1163497
Manufacturer # RT-CV19-20
Brand RightSign™
Manufacturer Premier Biotech
Application Rapid Test Kit
CLIA Classification CLIA Waived for Fingerstick Whole Blood
Contents (20) Cassettes, 1 X 3 mL Buffer, (20) Capillaries, Package Insert, Procedure Card, (20) Lancets, (20) Pads
For Use With For the Qualitative Detection of SARS-CoV-2 Antibodies in Whole Blood, Serum or Plasma
Number of Tests 20 Tests
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Reading Type Visual Read
Sample Type Whole Blood / Serum / Plasma Sample
Storage Requirements USP Controlled Room Temperature
Technology Lateral Flow Technology
Test Format Cassette Format
Test Method Rapid Chromatographic Immunoassay
Test Name COVID-19 IgG / IgM
Test Type Antibody Test
Time To Results 10 Minute Results
UNSPSC Code 41116205
Volume 3 mL Buffer
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  • Testing of serum, plasma and venous whole blood specimens is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity testsAND NO LONGER AVAILABLE
  • Testing of fingerstick whole blood specimens 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 high, moderate or waived complexity tests
  • Testing of fingerstick whole blood specimens 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
  • RightSign™ COVID-19 IgG/IgM Rapid Test Cassette is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection
  • RightSign™ COVID-19 IgG/IgM Rapid Test Cassette should not be used to diagnose acute SARS-CoV-2 infection
  • Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
  • False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes
  • Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG or IgM assay
  • RightSign™ COVID-19 IgG/IgM Rapid Test Cassette is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in in human venous whole blood (sodium heparin, EDTA, and sodium citrate), serum or plasma (sodium heparin, potassium EDTA and sodium citrate)
  • This test uses anti-human IgM antibody (test line IgM), anti-human IgG (test line IgG) and goat anti-mouse IgG (control line C) immobilized on a nitrocellulose strip
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb3(b)(1), unless the authorization is terminated or revoked sooner