Home / Clinical Laboratory / Controls / Control Swab / Antigen Test Control Swab BinaxNOW™ COVID-19 Ag Positive Level 10 Swabs195080
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Antigen Test Control Swab BinaxNOW™ COVID-19 Ag Positive Level 10 Swabs195080

Antigen-Test-Control-Swab-BinaxNOW™-COVID-19-Ag-Positive-Level-10-Swabs195080

SKU #

#1186180

MPN #

195080

Brand

Abbott Rapid Dx North America LLC

Stock

In Stock

Quantity

100

Features

CONTROL, COVID-19 AG BINAX NOW10 POS SWAB (10TEST/KT)

$71.52 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1186180
Manufacturer # 195080
Brand BinaxNOW™
Manufacturer Abbott Rapid Dx North America LLC
Application Control Swab
For Use With For use with BinaxNOW™ COVID-19 Ag Card
Form Swab
Levels Positive Level
Product Dating McKesson Acceptable Dating: we will ship >= 60 days
Test Name COVID-19 Ag
Test Type Antigen Test
UNSPSC Code 41116145
Volume 10 Swabs
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  • BinaxNOW COVID-19 Ag Card 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
  • 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
  • The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from anterior nasal (nares) swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within seven days of the onset of symptoms
  • Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
  • Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status
  • Positive results do not rule out bacterial infection or co-infection with other viruses
  • Negative results should be treated as 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