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LumiraDx Inc  |  SKU: L016000109048_EA

Respiratory Test Kit LumiraDx™ SARS-CoV-2 Ag 48 Tests CLIA Waived

$833.52
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Description

  • Results in 12 minutes
  • Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen; antigen is generally detectable in nasal swab specimens during the acute phase of infection.
  • The LumiraDx SARS-CoV-2 Ag test does not differentiate between SARS-CoV and SARS-CoV-2.
  • Rapid microfluidic immunofluorescence assay test method
  • LumiraDx SARS-CoV-2 Ag Test is for use under an Emergency Use Authorization only.
  • 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.
  • 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.
  • LumiraDx SARS-CoV-2 Ag Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings, and proficient in performing tests using the LumiraDx Instrument.
  • 48 tests

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