For in vitro diagnostic use. Others LumiraDx SARS-CoV-2 Flu AB IVD LumiraDx SARS-CoV-2 & Flu A/B PID00000899 10 443 057 001 10443057001 LumiraDx SARS-CoV-2&Flu A/B (24T) ML03 LumiraDx SARS-CoV-2&Flu A/B (24T) ML03 05060537712468 Reagents, kits L019000104024 24 tests Not Available undefined 10 418 222 001 10418222001 LumiraDx SARS-CoV-2&Flu A/B (24T) ML01 LumiraDx SARS-CoV-2&Flu A/B (24T) ML01 05060537712406 Reagents, kits L019000101024 24 tests Not Available undefined 10 418 249 001 10418249001 LumiraDx SARS-CoV-2&Flu A/B (24T) ML02 LumiraDx SARS-CoV-2&Flu A/B (24T) ML02 05060537712437 Reagents, kits L019000102024 24 tests Not Available undefined 10 418 257 001 10418257001 LumiraDx SARS-CoV-2&Flu A/B (24T) JP LumiraDx SARS-CoV-2&Flu A/B (24T) JP 05060537712833 Reagents, kits L019000107024 24 tests Not Available undefined The LumiraDx SARS-CoV-2 & Flu A/B test is a rapid microfluidic immunofluorescence assay for use with the LumiraDx instrument for the qualitative detection and differentiation of SARS-CoV-2, influenza type A, and influenza type B viral antigens. The LumiraDx SARS-CoV-2 & Flu A/B test uses nasal swab specimens. The test procedure involves taking a sample and adding to an extraction buffer. Then one drop of sample from the extraction buffer vial is added to the sample application area of the Test Strip. The LumiraDx Instrument is programmed to perform the analysis when the specimen has reacted with the reagents. The analysis is based on the amount of fluorescence the Instrument detects within the measurement area of the Test Strip. The concentration of the analyte in the specimen is directly proportional to the fluorescence detected. The results are displayed on the Instrument touchscreen within 12 minutes from the addition of specimen. en The LumiraDx SARS-CoV-2 & Flu A/B test is an automated rapid microfluidic immunofluorescence assay for use with the LumiraDx Platform, for near-patient testing, intended for the qualitative detection and differentiation of SARS-CoV-2, Influenza A and/or Influenza B viral antigens from nasal swab samples. Samples are collected from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. The LumiraDx SARS-CoV-2 & Flu A/B test is intended for use as an aid in the differential diagnosis of SARS-CoV-2, Influenza A, and Influenza B in humans and is not intended to detect Influenza C. The LumiraDx SARS-CoV-2 & Flu A/B test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification and differentiation of SARS-CoV-2, Influenza A and/or Influenza B nucleocapsid viral antigens. Viral antigens are generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of active infection but do not rule out bacterial infection or co-infection with other pathogens not detected by the test. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease. Negative results do not rule out SARS-CoV-2, Influenza A, and/or Influenza B infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management. The LumiraDx SARS-CoV-2 & Flu A/B 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. en

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