Class 2 Device Recall OrthoClinical Diagnostics | 合法醫療器材資訊網
2020年5月8日—VITROSChemistryProductsCKMBSlides,CreatineKinaseMB,ProductCode8001133-90slides,UDINumber10758750004201-Product ...
References Related Medical Device Recalls (www.accessdata.fda.gov) K861387 (www.accessdata.fda.gov) Differential rate kinetic method, cpk or isoenzymes (www.accessdata.fda.gov) JHS (www.accessdata.fda.gov) TPLC Device Report (www.accessdata.fda.gov) medical device recalls (www.fda.gov) Code of Federal Regulations (CFR) Title 21 §7.55 (www.accessdata.fda.gov) 510(K)s with Product Code = JHS and Original Applicant = EASTMAN KODAK COMPANY (www.accessdata.fda.gov) Date Initiated by Firm April 01, 2020 Create Date May 08, 2020 Recall Status1 ...
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Class 2 Device Recall Ortho Clinical Diagnostics (OCD ... | 合法醫療器材資訊網
2021年1月5日 — for Recall, VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference. FDA Determined Read More
Class 2 Device Recall OrthoClinical Diagnostics | 合法醫療器材資訊網
2020年5月8日 — VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product ... Read More
Class 2 Device Recall VITROS Chemistry Products CKMB ... | 合法醫療器材資訊網
2013年11月15日 — VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 ... Read More
URGENT FIELD SAFETY NOTICE VITROS® Chemistry ... | 合法醫療器材資訊網
Intended Use: VITROS Chemistry Products Slides quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT ... Read More
URGENT PRODUCT CORRECTION NOTIFICATION | 合法醫療器材資訊網
2019年4月4日 — VITROS Chemistry Products CK Slides on VITROS 250 or 350 ... VITROS CK Slides together with VITROS CK-MB Slides may be used to aid in ... Read More
URGENT PRODUCT CORRECTION NOTIFICATION VITROS ... | 合法醫療器材資訊網
2020年12月16日 — Intended Use: VITROS Chemistry Products Slides quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5, ... Read More
VITROS 250 CK | 合法醫療器材資訊網
VITROS 250 CK-MB Slide For Vitros 250/350, 950, 5,1 FS, 4600 Chemistry Systems/Vitros 5600 Integrated Systems 90/Box. Read More
VITROS CHEMISTRY PRODUCTS CKMB SLIDES 8001133 ... | 合法醫療器材資訊網
VITROS CHEMISTRY PRODUCTS CKMB SLIDES 8001133. MAUDE Adverse Event Report. MAUDE data represents reports of adverse events involving ... Read More
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