For in vitro diagnostic use. Others LumiraDx INR IVD LumiraDx INR PID00000894 10 418 010 001 10418010001 LumiraDx INR Test (48T) ML01 LumiraDx INR Test (48T) ML01 05060537711409 Reagents, kits L003000101048 48 tests Not Available undefined 10 443 065 001 10443065001 LumiraDx INR Test (48T) ML03 LumiraDx INR Test (48T) ML03 05060537711430 Reagents, kits L003000104048 48 tests Not Available undefined 10 418 028 001 10418028001 LumiraDx INR Test (48T) ML02 LumiraDx INR Test (48T) ML02 05060537711416 Reagents, kits L003000102048 48 tests Not Available undefined The LumiraDx INR Test Strips are intended for use with the LumiraDx Instrument. It is for use by healthcare professionals for quantitative prothrombin time testing, reported as International Normalized Ratio (INR), for the monitoring of oral anticoagulation therapy with Vitamin-K Antagonist (VKA) drugs. The test uses fresh capillary blood. It is intended for use in patients 18 years of age or older. en The LumiraDx INR Test is a thrombin activation assay in which a quenched substrate is cleaved by thrombin and the emitting fluorescence is detected and quantified. When a blood sample is applied to the Test Strip, the clotting cascade that proceeds naturally leads to the conversion of prothrombin to thrombin which, subsequently, recognizes a peptide sequence on the substrate. Following cleavage of this peptide sequence, the substrate becomes unquenched and emits a fluorescent signal detectable by the LumiraDx Instrument. The amount of signal detected over a specific time is converted by means of an algorithm into standardized coagulation units (INR) and the result is displayed on the touch-screen. en

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