US4387160A | 合法醫療器材資訊網
Creatine kinase (CK) occurs in animal body fluids and tissue in the form of three known isoenzymes, designated CK-BB, CK-MM and CK-MB. Each of these three isoenzymes, namely CK-BB, CK-MM, and CK-MB, differs one from the other by virtue of containing a different combination of subunits designated M or B. CK-BB has two B subunits, CK-MM has two M subunits, and CK-MB has one M and one B subunit. Determining the presence of CK-MB in biological fluids, especially in a patients serum, has become very useful in the diagnosis of myocardial infarction. (Galen, RS., Human Path 6: No. 2, 145-147, Apr. 1975).
Current immunological methods for determining the presence of CK-MB and the disadvantages of such methods have recently been reported and reviewed (Current Problems in Cardiology, Vol. III, No. 12, March, 1979 p. 7-28). These methods have not been very satisfactory in resolving the di...
510(k) Substantial Equivalence Determination Decision ... | 合法醫療器材資訊網
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ROCHE DIAGNOSTICS OPERATIONS | 合法醫療器材資訊網
Standardization of Creatine Kinase | 合法醫療器材資訊網
US4387160A | 合法醫療器材資訊網
【羅氏肌酸激酶同功異構酶液態生化檢驗試劑】許可證字號:衛署醫器輸字第014638號
器材品名:羅氏肌酸激酶同功異構酶液態生化檢驗試劑許可證字號:衛署醫器輸字第014638號註銷狀態:註銷日期:註銷理由:有效日期:...