''西門子'' C型肝炎病毒量檢測試劑
Versant HCV RNA 3.0 Assay (bDNA)

適應症
利用核酸探針雜交放大信號定量分析系統，直接定量檢測C型肝炎病毒感染者血清或血漿中的C型肝炎病毒核醣核酸含量。本檢驗法旨在輔助治療C型肝炎患者，不用於診斷或確認C型肝炎病毒感染。  
劑型
 
包裝
124059 
許可證字號
衛部藥製字第017223號 
註銷狀態
1 
註銷日期
2018-07-31  
註銷理由
851 
有效日期
2016-07-14  
發證日期
2006-07-14  
許可證種類
09 
中文品名
''西門子'' C型肝炎病毒量檢測試劑 
英文品名
Versant HCV RNA 3.0 Assay (bDNA) 
藥品類別
B 血液學及病理學裝置 
申請商名稱
西門子股份有限公司  
申請商地址
台北市南港區園區街３號８樓 
通關簽審文件編號
DHA00601722308 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
SIEMENS HEALTHCARE DIAGNOSTICS INC. 333 CONEY ST. EAST WALPOLE, MA 02032, U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 BOX 1\nLysis Diluent (1x15mL): buffered protein solution, sodium azide (< 0.1%), preservatives\nLysis Reagent (1x2.2mL): proteinase K solution, sodium azide (< 0.1%), preservatives\nCapture Probes (1x120mL): synthetic oligonucleotides, buffered solution, sodium azide (< 0.1%), preservatives\nTarget Probes (1x120mL): synthetic oligonucleotides, buffered solution, sodium azide (< 0.1%), preservatives\nWash A (2x440mL): buffered solution, sodium azide (< 0.1%), preservatives\nWash B (2x320mL): buffered solution, sodium azide (< 0.1%), preservatives\nCapture Wells (8 strips/12 wells each): polystyrene microwells coated with synthetic oligonucleotides\nBarrier Film (1x6 sheets): high density polyethylene sheets\nPre-Amplifier/Amplifier Diluent (1x28mL): buffered protein solution, sodium azide (< 0.1%), preservatives\nLabel Diluent (1x15mL): buffered protein solution, sodium azide (< 0.1%), preservatives\nDextran Sulfate (1x14mL): 40% dextran sulfate solution, sodium azide (< 0.1%), preservatives
1 Pre-Amplifier Probes (1x130mL): synthetic oligonucleotides, buffered solution, sodium azide (< 0.1%), preservatives\nAmplifier Probe (1x130mL): synthetic oligonucleotides, buffered solution, sodium azide (< 0.1%), preservatives\nSubstrate (1x12mL): chemiluminescent substrate (Lumi-Phos&reg; Plus)\nSubstrate Enhancer (1x1.2mL): aqueous solution, sodium azide (< 0.1%), preservatives\n
1 BOX 2\nLabel Probe (1x140mL): enzyme-labeled synthetic oligonucleotides, buffered solution, sodium azide (< 0.1%), preservatives\nHigh Positive Control (4x105mL): human plasma containing recombinant single stranded phage DNA, sodium azide (< 0.1%), preservatives\nLow Positive Control (4x105mL): human plasma containing BPL-treated HCV, sodium azide (< 0.1%), preservatives\nNegative Control (4x105mL): human plasma nonreactive for HCV, sodium azide (< 0.1%), preservatives\nStandards A, D (1x440mL/level): human plasma containing recombinant single stranded phage DNA, sodium azide (< 0.1%), preservatives\nStandards B, C (1x220mL/level): human plasma containing recombinant single stranded phage DNA, sodium azide (< 0.1%), preservatives\nStandard E (1x660mL): human plasma containing recombinant single stranded phage DNA, sodium azide (< 0.1%), preservatives\n