For in vitro diagnostic use. Others LumiraDx CRP IVD LumiraDx CRP PID00000891 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 C-Reactive Protein (CRP) Test Strips (hereafter referred to as Test Strips) are to be used with the LumiraDx Platform. The LumiraDx Platform is a point of care system for professional use which is used for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test. This test is for HEALTHCARE PROFESSIONAL USE ONLY and allows users to perform tests using small sample volumes and to view results quickly on the Instrument touch-screen. en 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

体外診断用医薬品	製造販売承認番号：306AIEZX00001000
測定原理	マイクロ流体免疫蛍光法
検体種	毛細血管全血（指先穿刺血）、静脈全血（ヘパリンリチウム）、または血漿（ヘパリンリチウム）
検体量	約20µL
測定時間	約4分
正確性	<10% CV
測定範囲	0.5-25.0 mg/dL
保存条件	2～30℃
統一商品コード	518-636906
包装	24テスト

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