Home / Clinical Laboratory / Controls / Control / Antibody Test Control Biotime SARS-CoV-2 IgG / IgM Positive Level 100 µL5300000979
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Antibody Test Control Biotime SARS-CoV-2 IgG / IgM Positive Level 100 µL5300000979

Antibody-Test-Control-Biotime-SARS-CoV-2-IgG--IgM-Positive-Level-100-µL5300000979

SKU #

#1181421

MPN #

5300000979

Brand

Horiba

Stock

In Stock

Quantity

100

Features

CONTROL, BIO TIME SARS-COV -2 IGG/IGM

$144.91 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1181421
Manufacturer # 5300000979
Brand Biotime
Manufacturer Horiba
Application Control
Container Type Vial
For Use With For Quality Control of Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test
Form Lyophilized
Levels Positive Level
Product Dating McKesson Acceptable Dating: we will ship >= 30 days
Test Name SARS-Cov-2 IgG / IgM
Test Type Antibody Test
UNSPSC Code 41116128
Volume 100 µL
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  • Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test assay is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • This test has been authorized by FDA under an EUA for use by laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests
  • Biotime SARS-CoV-2 IgG/IgM Control consists of 1 positive control; positive control is made of recombinantly expressed human anti-SARS-CoV-2 IgG, IgM antibodies and bovine serum - it is not the antibodies derived from patients infected with SARS-CoV-2
  • 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the authorization is terminated or revoked sooner
  • At this time, it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity
  • Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
  • Negative results do not preclude acute SARS-CoV-2 infection; if acute infection is suspected, direct testing for SARS-CoV-2 is necessary
  • A positive result may not indicate previous SARS-CoV-2 infection; consider other information including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an immune response
  • Control ID: FDS01 (1 vial/set): 100μL/vial