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"Sabia" gel alkaline phosphatase isoenzyme electrophoresis kit - Taiwan Registration f55fed0aa332785460148cadd2be1c80

Access comprehensive regulatory information for "Sabia" gel alkaline phosphatase isoenzyme electrophoresis kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f55fed0aa332785460148cadd2be1c80 and manufactured by SEBIA. The authorized representative in Taiwan is ARQon Medtech Co., Ltd..

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f55fed0aa332785460148cadd2be1c80
Registration Details
Taiwan FDA Registration: f55fed0aa332785460148cadd2be1c80
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Device Details

"Sabia" gel alkaline phosphatase isoenzyme electrophoresis kit
TW: โ€œ่ณฝๆฏ”ไบžโ€ ๅ‡่† ้นผๆ€ง็ฃท้…ธ้…ถๅŒๅŠŸ้…ถ้›ปๆณณๅฅ—็ต„
Risk Class 2

Registration Details

f55fed0aa332785460148cadd2be1c80

DHA05603047100

Company Information

France

Product Details

This product is used to detect and quantify alkaline phosphatase isoenzymes in human serum. This product is used in the semi-automatic HYDRASYS electrophoresis system to analyze the results obtained on film. Serum samples were separated by film electrophoresis in alkaline buffer (pH 9.4), and alkaline phosphatase isoenzymes were chromotropically colored. The dried electrophoretic film was visually inspected and the precise relative content of each segment was measured with an optical density analyzer.

A Clinical chemistry and clinical toxicology

A.1050 Phosphatase or isoenzyme test system;; A.1660 Quality control materials (analytical and non-analytical)

import

Dates and Status

Dec 15, 2017

Dec 15, 2027