| 許可證字號 |
衛署醫器輸壹字第001744號
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| 註銷狀態 |
已註銷
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| 註銷日期 |
2012/11/19
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| 註銷理由 |
許可證已逾有效期
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| 有效日期 |
2010/11/04
|
| 發證日期 |
2005/11/04
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| 許可證種類 |
09
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| 舊證字號 |
|
| 醫療器材級數 |
1
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| 通關簽審文件編號 |
DHA04400174407
|
| 中文品名 |
拜爾斯達光學免疫法披衣菌測定試劑
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| 英文品名 |
BioStar CHLAMYDIA 0IA
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| 效能 |
檢測子宮頸內棉棒檢體中的披衣菌抗原。
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| 劑型 |
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| 包裝 |
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| 醫器主類別一 |
C 免疫學及微生物學
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| 醫器次類別一 |
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| 醫器主類別二 |
|
| 醫器次類別二 |
|
|
|
| 醫器主類別三 |
|
| 醫器次類別三 |
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| 主成分略述 |
Reagent 1A:\nExtraction Reagent: pH 6.0 buffer solution containing dithioerythritol and a broad spectrum protease.\nReagent 1B:\nExtraction Reagent: pH 13.0 buffer solution containing chenodeoxycholic acid.\nReagent 2:\nneutralizer: pH 7.0 buffer solution containing guanidine-HCl preserved with 0.5% ProClin 300 Preservative.\nReagent 3:\nConjugae: pH 8.0 buffered protein solution containing anti (C. trachomatis) antibody (murine) conjugated to Horseradish peroxidase (HRP) and preserved with 0.5% ProClin 300 solution.\nReagent 4:\nWash Solution: pH 7.8 saline buffer preserved with 0.1% ProClin 300 preservative.\nSubstrate:\npH 5.5 aqueous solution of tetramethylbenzidine (TMB) and hydrogen peroxide.\nPositive Control:\npH 7.0 protein solution containing inactivated C. trachomatis and preserved with 0.5% ProClin 300 preservative.\nTest Devices:\nProtein coated surface spotted with goat anti-moue IgG as a procedural control.\n
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| 醫器規格 |
#CHL30: 30 tests/box
|
| 限制項目 |
輸 入
|
| 申請商名稱 |
瑞博企業有限公司
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| 申請商地址 |
新北市永和區中山路一段174號11樓
|
| 申請商統一編號 |
89602027
|
| 製造商名稱 |
THERMO ELECTRON CORPORATION
|
| 製造廠廠址 |
331 SOUTH 104TH STREET LOUISVILLE, CO 80027 USA
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| 製造廠公司地址 |
|
| 製造廠國別 |
US
|
| 製程 |
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| 異動日期 |
2012/11/19
|
| 製造許可登錄編號 |
|