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Abbott Laboratories 195000

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BinaxNOW™ Professional Use Antigen Detection COVID-19 Ag Nasal Swab Sample 40/Pk

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Was: $832.95
Your Price: $417.95

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MFR:
195000
Medex SKU:
ADE-195000
Packing Info:
40/Pack
Usually Ships:
4 - 6 Weeks
Freight Quote Button:
False
Notice:
Due to regulatory requirements, this item can only be shipped to customers who have a valid Medical license on file. To add your license information, please click here

Description

  • 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
  • The BinaxNOW COVID-19 Ag Card is intended for use by medical professionals or trained operators who are proficient in performing rapid lateral flow tests
  • The BinaxNOW COVID-19 Ag Card does not differentiate between SARSCoV and SARS-CoV-2
  • Sensitivity (PPA) 84.6% (entire population)
  • Sensitivity (PPA) 95.6% (those with PCR cycle threshold [Ct] < 33)
  • Specificity (NPA) 98.5%
  • Onboard extraction allows the swab to be directly inserted into the test card
  • Visually read results in 15 minutes - no instrument required

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