Taiwan FDA registration f55fed0aa332785460148cadd2be1c80

"Sabia" gel alkaline phosphatase isoenzyme electrophoresis kit

TW: “賽比亞” 凝膠鹼性磷酸酶同功酶電泳套組

Taiwan·Risk Class 2·SEBIA·Registered Dec 15, 2017 – Dec 15, 2027Active

Registration details

Analysis ID: f55fed0aa332785460148cadd2be1c80
Customs Code: DHA05603047100

Company information

Manufacturer: SEBIA
Manufacturer Country: France
Authorized Representative: ARQon Medtech Co., Ltd.

Product details

Intended Use: 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.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1050 Phosphatase or isoenzyme test system;; A.1660 Quality control materials (analytical and non-analytical)
Import Information: import

Dates and status

Registration Date: Dec 15, 2017
Expiry Date: Dec 15, 2027

About this record

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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