美利迪恩新型隱球菌抗原乳膠凝集檢測系統 (未滅菌)
CALAS (Cryptococcal Antigen Latex Agglutination System) (Non-Sterile)

適應症
定性及半定量偵測人體血清和腦脊髓中的新型隱球菌抗體的英膜多醣。  
劑型
 
包裝
140100 
許可證字號
44000565 
註銷狀態
0 
註銷日期
 
註銷理由
 
有效日期
2025-09-23  
發證日期
2005-09-23  
許可證種類
09 
中文品名
美利迪恩新型隱球菌抗原乳膠凝集檢測系統 (未滅菌) 
英文品名
CALAS (Cryptococcal Antigen Latex Agglutination System) (Non-Sterile) 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
碩景股份有限公司  
申請商地址
台北市信義區松德路７４號８樓 
通關簽審文件編號
DHA04400056502 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
MERIDIAN BIOSCIENCE, INC 3471 RIVER HILLS DRIVE, CINCINNATI, OH 45244, U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 Sample Diluent (50ml). Glycine buffered saline (pH 8.4 ± 0.1) containing bovine serum albumin and a preservative.
1 Detection Latex (4ml). Standardized latex particles coated with an optimal dilution of rabbit anticryptococcal globulin, in glycine buffered saline (pH 8.4 ± 0.1) containing a preservative.
1 Control Latex (5ml). Standardized latex particles coated with an optimal dilution of normal rabbit globulin, in glycine buffered saline (pH 8.4 ± 0.1) containing a preservative.
1 Antibody Control (1.5ml). Lyophilized goat anti-rabbit serum containing a preservative.
1 Negative Control (2.5ml). Lyophilized normal human serum containing a preservative. Each donor unit used in the preparation of this reagent has been found to be nonreactive for Hepatitis B surface antigen, anti-Hepatitis C and HIV-I/ II antibodies by FDA approved test procedures.
1 Positive Control (2.5ml). Purified Cryptococcus neoformans polysaccharide antigen containing a preservative.
1 Pronase (2 x 2.5ml). Lyophilized with preservative. Each vial contains enough enzyme to treat 10 serum specimens. Meridian catalog #140050.
1 Disposable Reaction Cards (2 x 20/pk).
1 Reaction Reference Photograph (1).
1 Package Insert (1).
1 Catalog #140100 provides enough reagents to perform 50-100 tests depending on the number of controls and titrations included per test run.