510(k) Substantial Equivalence Determination Decision ... | 合法醫療器材資訊網
ClinicallaboratoriescanusetheSynermedIR-1200chemistryanalyzerforinvitro...ThesponsorrecommendstheuseofSynermedIRCalIIcalibratorforthe ...
Clinical laboratories can use the Synermed IR-1200 chemistry analyzer for in vitro ... The sponsor recommends the use of Synermed IR Cal II calibrator for the ...
Synermed IR Cal II Synermed IR Cal II Podf IOL Olympus fluorescence laparoscopy Uces 3 Olympus endoscopy system 朝舜儀器有限公司 前足真空護具價格 明傑企業社快篩試劑 明杰工業社
喜樂美IR校正液II Synermed IR Cal II} | 合法醫療器材資訊網
喜樂美IR校正液II Synermed IR Cal II / 用於校正Synermed IR200分析儀、Synermed IR500分析儀、Hitachi系列分析儀、AU5000分析儀、AM Diagnostics Excel ... Read More
A 相關藥品一覽 | 合法醫療器材資訊網
... 香港商生物梅里埃有限公司台灣分公司 台灣. 用於細菌的藥物感受性試驗。 喜樂美IR校正液II Synermed IR Cal II · 沒有影像 · 喜樂美IR校正液II Synermed IR Cal II ... Read More
SYNERMED INTERNATIONAL INC. 相關藥物 | 合法醫療器材資訊網
SYNERMED INTERNATIONAL INC. 藥物廠商; SYNERMED INTERNATIONAL INC. ... 喜樂美IR校正液II Synermed IR Cal II · 沒有影像 ... Read More
INFRARED LABORATORY SYSTEMS | 合法醫療器材資訊網
2016年6月24日 — The Synermed IR Cal II was previously cleared in K940571 and is traceable to NIST standard number 917-C; no modification was made. c. Read More
Federal Register | 合法醫療器材資訊網
... Modular Analytics ( 55619 ) Synermed IR 200 ( 58460 ) ANALYTE : Cancer Antigen 125 ( CA 125 ) ( 1049 ) Test System , Assay , Examination : Abbott AxSYM ... Read More
April 19, 2018 Infrared Laboratory Systems | 合法醫療器材資訊網
2018年4月19日 — Re: k172416. Trade/Device Name: Synermed Opiate Enzyme Immunoassay ... If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to ... Programmable Cal/QC. Same. Read More
510(k) Substantial Equivalence Determination Decision ... | 合法醫療器材資訊網
Clinical laboratories can use the Synermed IR-1200 chemistry analyzer for in vitro ... The sponsor recommends the use of Synermed IR Cal II calibrator for the ... Read More
Calibrator and Controls | 合法醫療器材資訊網
IR CAL reference materials are human based protein materials that are used to calibrate analyzers which utilize Synermed reagent methods for the quantitative determination of the listed ... IR962-X, Affirm II, 12x5 mL reconstituted, 60, 0-4° C ... Read More
Calcium | 合法醫療器材資訊網
The Synermed® IR240 method is optimized for both 'on board' calibration stability and performance at 600 ... Arsenazo III + Ca+2 -> Arsenazo III - Ca+2 complex Read More
相關資訊整理
【喜樂美IR校正液II】許可證字號:衛署醫器輸字第017177號
器材品名:喜樂美IR校正液II許可證字號:衛署醫器輸字第017177號註銷狀態:已註銷註銷日期:2012/11/26註銷理由:許可證已逾有效...