For in vitro diagnostic use. Others LumiraDx CRP IVD LumiraDx CRP PID00000891 10 443 049 001 10443049001 LumiraDx CRP Test (24T) ML03 LumiraDx CRP Test (24T) ML03 05060537711683 Reagents, kits L004000104024 24 tests Not Available undefined 10 418 044 001 10418044001 LumiraDx CRP Test (24T) ML01 LumiraDx CRP Test (24T) ML01 05060537711652 Reagents, kits L004000101024 24 tests Not Available undefined 10 418 052 001 10418052001 LumiraDx CRP Test (24T) ML02 LumiraDx CRP Test (24T) ML02 05060537711669 Reagents, kits L004000102024 24 tests Not Available undefined 10 418 079 001 10418079001 LumiraDx CRP Test (24T) JP LumiraDx CRP Test (24T) JP 05060537713151 Reagents, kits L004000107024 24 tests Not Available undefined The LumiraDx CRP Test is a single use fluorescence immunoassay device designed to determine the concentration of CRP in human whole blood (direct fingerstick or Lithium Heparin-venous) and Lithium Heparin plasma specimens. The test procedure involves the addition of fingerstick, venous whole blood or plasma sample to the sample application area of the Test Strip inserted in the Instrument. The Instrument is programmed to perform the analysis when the sample has reacted with the reagents within the Test Strip. 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 sample is proportional to the fluorescence detected. The results are displayed on the Instrument touch-screen in 4 minutes from the addition of sample. en The LumiraDx CRP Test Strips are intended for use with the LumiraDx Instrument. It is an automated in vitro diagnostic test for near-patient testing, for use by healthcare professionals, for the quantitative determination of C-Reactive Protein in human whole blood (capillary fingerstick and venous) and plasma samples. The measurement of CRP provides information for the detection and evaluation of infection, tissue injury, inflammation disorders, and associated disease. It is intended for use in patients 2 years of age or older. en

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