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and photocreatine kinase MB isoenzyme correction solution and quality control solution - Taiwan Registration 65f0a9beabc4847f3084a72202089cfc

Access comprehensive regulatory information for and photocreatine kinase MB isoenzyme correction solution and quality control solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 65f0a9beabc4847f3084a72202089cfc and manufactured by FUJIFILM WAKO PURE CHEMICAL CORPORATION MIE PLANT. The authorized representative in Taiwan is MEDICARE PRODUCTS INC..

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65f0a9beabc4847f3084a72202089cfc
Registration Details
Taiwan FDA Registration: 65f0a9beabc4847f3084a72202089cfc
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Device Details

and photocreatine kinase MB isoenzyme correction solution and quality control solution
TW: 和光肌酸激酶 MB 同功酶校正液及品管液
Risk Class 2

Registration Details

65f0a9beabc4847f3084a72202089cfc

DHA05603709109

Company Information

Product Details

校正液: 本產品校正液用於基於免疫抑制法CKMB檢測試劑的校正. 應與 Wako L-Type CK 或 Wako L-Type CK-MB 一起使用. 品管液: 本產品品管液用於臨床實驗室的品質監控,以監測基於免疫抑制法CKMB檢測試劑的準確性和精密度. 應與 Wako L-Type CK 或 Wako L-Type CK-MB 一起使用.

A Clinical chemistry and clinical toxicology

A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration

QMS/QSD;; 輸入

Dates and Status

Jul 17, 2024

Jul 17, 2029