羅氏泰能康D | 合法醫療器材資訊網
衛署醫器輸字第022014號,台灣羅氏醫療診斷設備股份有限公司,羅氏泰能康D-二聚體第2代檢驗試劑·Roche/HitachiTina-quantD-DimerGen.2.
衛署醫器輸字第022014號, 台灣羅氏醫療診斷設備股份有限公司, 羅氏泰能康D-二聚體第2代檢驗試劑· Roche/Hitachi Tina-quant D-Dimer Gen.2.
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羅氏泰能康D | 合法醫療器材資訊網
衛署醫器輸字第022014號, 台灣羅氏醫療診斷設備股份有限公司, 羅氏泰能康D-二聚體第2代檢驗試劑· Roche/Hitachi Tina-quant D-Dimer Gen.2. Read More
羅氏泰能康D | 合法醫療器材資訊網
羅氏泰能康D-二聚體第2代檢驗試劑於醫療器材許可證資料集。中文品名:羅氏泰能康D-二聚體第2代檢驗試劑,英文品名:Roche/Hitachi Tina-quant D-Dimer Gen.2 ... Read More
羅氏泰能康D | 合法醫療器材資訊網
英文品名, Roche/Hitachi Tina-quant D-Dimer Gen.2. 效能, 在Roche/Hitachi 902/912/914/MODULAR P 分析儀上,以免疫濁度分析法對人類血漿進行纖維蛋白分解 ... Read More
羅氏可霸斯泰能康D | 合法醫療器材資訊網
英文品名, cobas Tina-quant D-Dimer Gen.2. 效能, 在Roche/Hitachi cobas c 311/501/502系統上,對人類血漿進行纖維蛋白分解產物(D-二聚體和X-寡聚體)的定量 ... Read More
upload | 合法醫療器材資訊網
04912497 190 Tina-quant D-Blmer G 2 11 x 15 mL, [2] 1 x 15 mL). Roche/Hitachi 902, Roche/Hitachi MODULAR P. 05050901 190 D-Dimer Gen2 Calibrator Set ... Read More
Evaluating the analytical performance of four new coagulation ... | 合法醫療器材資訊網
由 S Kitchen 著作 · 2018 · 被引用 4 次 — assays for the measurement of fibrinogen, D- dimer and thrombin ... vs Tina- quant® D- Dimer Gen 2 reagent on Roche/Hitachi cobas c systems ... Read More
Tinaquant D-Dimer Gen 11 RocheHitachi 902 | 合法醫療器材資訊網
Internaiobservations with D-Dimer Gen. 2 revealed that reagent lots 62838001,. 62837701 and 62841101 show an unusual signal increase when tested. Read More
1 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION ... | 合法醫療器材資訊網
The Roche diagnostics Tina-Quant D-dimer assay is an immunoturbidimetric assay ... Biomerieux Vidas D-Dimer Exclusion Assay. 2. Predicate 510(k) number(s): ... d. Detection limit: Roche/Hitachi: COBAS Integra: 0.04 µg FEU/mL. <0.08 µg ... Read More
Clinical Performance of the Tina | 合法醫療器材資訊網
Aims: Evaluate the clinical performance of the new Tina-quant® D-Dimer Gen 2 assay (cobas t 711 analyser; Roche Diagnostics) for identifying patients with ... Read More
Tina-quant@ D | 合法醫療器材資訊網
51 O(k) Summary - Tina-quant@ D-Dimer Test System. Art? 0 1 2003 ... 510(k) Summary - COBAS Integra Creatinine plus ver.2, ... D-dimer on Roche Hitachi. Read More
相關資訊整理
【羅氏泰能康D-二聚體第2代檢驗試劑】許可證字號:衛署醫器輸字第022014號
器材品名:羅氏泰能康D-二聚體第2代檢驗試劑許可證字號:衛署醫器輸字第022014號註銷狀態:註銷日期:註銷理由:有效日期:2021/05...