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⚠️ 此醫材許可證已註銷
狀態:已註銷 日期:2018/07/31
原因:未展延而逾期者
''西門子'' C型肝炎病毒量檢測試劑
🩺 醫材Versant HCV RNA 3.0 Assay (bDNA)
衛署醫器輸字第017223號
醫材分類
第 3 等級
- B.4020分析特定試劑
醫器規格
124059
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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。
醫材資訊
- 主成分
- 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 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® Plus)\nSubstrate Enhancer (1x1.2mL): aqueous solution, sodium azide (< 0.1%), preservatives\n 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
- 製造商
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- 製造國
- US
- 申請商
- 西門子股份有限公司
- 有效日期
- 2016/07/14
- 發證日期
- 2006/07/14
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目前尚無登錄供應此品項的藥局資料。