For in vitro diagnostic use. Others LumiraDx NT-proBNP IVD LumiraDx NT-proBNP PID00000895 10 418 346 001 10418346001 LumiraDx NT-proBNP Test (12T) JP LumiraDx NT-proBNP Test (12T) JP 05060537714820 Reagents, kits L023000107012 12 tests Not Available undefined 10 443 081 001 10443081001 LumiraDx NT-proBNP Test (12T) ML03 LumiraDx NT-proBNP Test (12T) ML03 05060537714943 Reagents, kits L023000104012 12 tests Not Available undefined 10 418 320 001 10418320001 LumiraDx NT-proBNP Test (12T) ML01 LumiraDx NT-proBNP Test (12T) ML01 05060537714615 Reagents, kits L023000101012 12 tests Not Available undefined 10 418 338 001 10418338001 LumiraDx NT-proBNP Test (12T) ML02 LumiraDx NT-proBNP Test (12T) ML02 05060537714912 Reagents, kits L023000102012 12 tests Not Available undefined The LumiraDx NT-proBNP test is an in vitro diagnostic test for the quantitative determination of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) in human capillary and venous whole blood and plasma samples (Lithium Heparin). The LumiraDx NT-proBNP Test Strips are intended for use with the LumiraDx Instrument. It is an automated in vitro diagnostic test for near-patient testing. The NT-proBNP test is intended to be used as an aid in the diagnosis of individuals suspected of having congestive heart failure (also referred to as heart failure). The LumiraDx NT-proBNP test is for Professional Use Only. For patients ≥18 years of age. en The LumiraDx NT-proBNP test is a rapid microfluidic immunofluorescence assay for use with the LumiraDx Instrument for the quantitative measurement of NT-proBNP 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. 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 12 minutes from the addition of sample. en

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