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

 Brand: LumiraDx Inc