510(k) SUBSTANTIAL EQUIVALENCE ... | 合法醫療器材資訊網
OOI-Real-TimeNucleicAcidAmplificationSystem.4.Panel:...Biosystems7500FastDx,ortheCepheidSmartCyclerII,todetectthetoxingene...theQuidelMolecularDirectC.difficileAssayhadnopredictedcross-reactivityforC....Forallexper
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510(k) SUBSTANTIAL EQUIVALENCE ... | 合法醫療器材資訊網
OOI - Real-Time Nucleic Acid Amplification System. 4. Panel: ... Biosystems 7500 Fast Dx, or the Cepheid SmartCycler II, to detect the toxin gene ... the Quidel Molecular Direct C. difficile Assay had no predicted cross-reactivity for C. ... For all exper Read More
k121942 B. Purpose for Submission | 合法醫療器材資訊網
preclude Adenovirus infection and should not be used as the sole basis for ... To be used with the Cepheid SmartCycler II utilizing Dx software version 1.7b or 3.0 ... system to extract adenovirus DNA from swab or wash specimens obtained from ... microcen Read More
Operator Manual | 合法醫療器材資訊網
Cepheid SmartCycler® System Software License Agreement. License Grant: Subject to the terms and conditions herein, Cepheid grants Customer a non-. Read More
ProFluPlus Package Insert Draft | 合法醫療器材資訊網
Isolate the Nucleic Acid (Pre-Amplification Area I) - MagNA Pure LC System . ... Sterile RNase/DNase-free filter or positive displacement micropipettor tips ... Cepheid SmartCycler II Real Time Instrument with Dx Software version 1.7b, 3.0a, or 3.0b ... О Read More
REVIEW MEMORANDUM | 合法醫療器材資訊網
Negative results do not preclude influenza or RSV virus infection and should not ... System (Roche) and the MagNA Pure Total Nucleic Acid Isolation Kit (Roche) or ... Sterile RNase/DNase-free filter or positive displacement micropipettor tips ... Cepheid Read More
SmartCycler® System | 合法醫療器材資訊網
SmartCycler®. System. Potentially the most sensitive real-time PCR system in the world. ... (expandable to 96) requires no warm-up time, no ... Cepheid's SmartTubes are sealed, pressurized polypropylene tube ... JP 3136129 and patents pending, for all Read More
賽飛斯瑪特賽可即時偵測PCR分析儀(未滅菌) · Cepheid SmartCycler ... | 合法醫療器材資訊網
衛署醫器輸壹字第007315號, 豐技生物科技股份有限公司, 賽飛斯瑪特賽可即時偵測PCR分析儀(未滅菌) · Cepheid SmartCycler DX system(Non-Sterile) Read More
醫療器材許可證資料集 | 合法醫療器材資訊網
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【賽飛 斯瑪特賽可即時偵測PCR分析儀(未滅菌)】許可證字號:衛署醫器輸壹字第007315號
器材品名:賽飛斯瑪特賽可即時偵測PCR分析儀(未滅菌)許可證字號:衛署醫器輸壹字第007315號註銷狀態:註銷日期:註銷理由:有效日...