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臺灣臺北地方法院107年度訴字第2375號

關鍵資訊

       1072375                          108 7 16 105 6 8 4,798,500 SureTechBD FACSMicroCount 3 106 3 285 4 5 18IQ/OQ 使1040101,919,400 30101,439,550 ) 3,358,950 107 4 23246 359 使27v .s465 5 475 8-22BD FACSMicro Count Performance Qualification Protocol 281 287 SOP 106 5 4 IQ/OQ 106 7 12< 0.5 log CV< 5%7 481 BD使IQ /OQ10367 3,358,950 3,358,950 105 6 8 104 8 3127FACSMicroCountBDFACSMicroCount < 1 Hour 調105 112424106 101924246 24106 7 141 FACSMicroCountCV< 5 106 10191020106 1227調退107 4 23359 365 6 246 359 104 8 31105 6 8 4,798,500 Sure Tech 106 3 28106 5 4 106 5 1811IQ /OQIQ/OQ 5177105 155 使使281 287 CV< 5 IQ /OQ10367 3,358,950 246 24CV< 5 10367 3,358,950 246 246 1 87281 246 1 113 226 259 260 24246 24使246 24CV< 5 373 5 354 359 104 8 31105 155 81232524416421114126127 420 153 245-90583-7 912 241054335 341 27131FACSMi croCountBD FACSMicroCount < 1 Hour調272449 153245-90245-9047151 5 8-2227 v.s221 24 157195 使242427使2724 117 IQ/OQ 4 7 305153106 3 28106 5 4 106 5 1811IQ /OQIQ/OQ 5777281 287 1 BD281 IQ/OQ IQ/OQ 使CV < 5 24CV< 5 359 10367 3,358,950 367 1040101,919,400 30101,439,550 ) 117 IQ/OQ 4 7 3051533,358,950 10367 3,358,950 10367 3,358,950 107 3 3 44 78 108 8 27 20 108 8 27