亞培 B 型肝炎病毒量檢驗套組
Abbott RealTime TM HBV

適應症
利用聚合酶連鎖反應(PCR)合併即時螢光偵測，定量B型肝炎感染者血漿或血清中之HBV病毒。  
劑型
 
包裝
# 2G34-70, # 2G34-80, # 2G34-90 變更規格、標籤仿單變更為：詳如中文仿單核定本（原101年1月13日仿單標籤核定本正本收回作廢）。 
許可證字號
衛部藥製字第020345號 
註銷狀態
0 
註銷日期
 
註銷理由
 
有效日期
2029-06-23  
發證日期
2009-06-23  
許可證種類
09 
中文品名
亞培 B 型肝炎病毒量檢驗套組 
英文品名
Abbott RealTime TM HBV 
藥品類別
B 血液學及病理學裝置 
申請商名稱
美商亞培股份有限公司台灣分公司  
申請商地址
臺北市中山區民生東路3段49號5樓、6樓及51號6樓 
通關簽審文件編號
DHA00602034506 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ABBOTT MOLECULAR INC. 1300 EAST TOUHY AVENUE, DES PLAINES, IL 60018, USA US
成份表
處方標示 成分名稱 含量 單位
1 Abbott RealTime HBV Amplification Reagent Kit (List No. 2G34-90)\n1. Abbott RealTime HBV Internal Control (List No. 2G34Y): 4 vials, 0.2 mL per vial\nLess than 0.01% noninfectious linearized DNA plasmid in a buffer solution.\nPreservatives: Sodium azide and 0.15% ProClin® 950.
1 2. Abbott RealTime HBV Amplification Reagent Pack (List No. 2G34): 4 packs, 24 tests/pack\n1 bottle (0.078 mL) Amplitaq Gold Enzyme (5.4 to 5.9 Units/μL) in a buffered solution with stabilizers.\n1 bottle (0.917 mL) HBV Oligonucleotide Reagent. Less than 0.1% synthetic oligonucleotides (4 primers and 3 probes), and less than 0.2% dNTPs in a buffered solution with a reference dye. Preservatives: Sodium azide and 0.15% ProClin 950.\n1 bottle (0.778 mL) Activation Reagent. 38 mM magnesium chloride in a buffered solution. Preservatives: Sodium azide and 0.15% ProClin 950.
1 Abbott RealTime HBV Control Kit (List No. 2G34-80)\n1. Abbott RealTime HBV Negative Control (List No. 2G34Z): 8 vials, 1.3 mL per vial\nNegative human plasma tested and found to be nonreactive for HBsAg, HBV DNA, HIV RNA, HCV RNA, anti-HIV-1/HIV-2, and anti-HCV. Preservatives: 0.1% ProClin 300 and 0.15% ProClin 950.
1 2. Abbott RealTime HBV Low Positive Control (List No. 2G34W): 8 vials, 1.3 mL per vial\nHeat-inactivated plasma reactive for HBV DNA in negative human plasma. Negative human plasma tested and found to be nonreactive for HBsAg, HBV DNA, HIV RNA, HCV RNA, anti-HIV-1/HIV-2, and anti-HCV. Preservatives: 0.1% ProClin 300 and 0.15% ProClin 950.
1 3. Abbott RealTime HBV High Positive Control (List No. 2G34X): 8 vials, 1.3 mL per vial\nHeat-inactivated plasma reactive for HBV DNA in negative human plasma. Negative human plasma tested and found to be nonreactive for HBsAg, HBV DNA, HIV RNA, HCV RNA, anti-HIV-1/HIV-2, and anti-HCV. Preservatives: 0.1% ProClin 300 and 0.15% ProClin 950.
1 Abbott RealTime HBV Calibrator Kit (List No. 2G34-70)\n1. Abbott RealTime HBV Calibrator A (List No. 2G34A): 12 vials, 1.3 mL per vial\nLess than 0.01% noninfectious linearized HBV DNA plasmid in a buffer solution. Preservatives: Sodium azide and 0.15% ProClin 950.
1 2. Abbott RealTime HBV Calibrator B (List No. 2G34B): 12 vials, 1.3 mL per vial\nLess than 0.01% noninfectious linearized HBV DNA plasmid in a buffer solution. Preservatives: Sodium azide and 0.15% ProClin 950.