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Roche Cobas aspartate aminotransferase second-generation biochemical assay reagent - Taiwan Registration 11d5b853d31ea8585568261a1bdfdaeb

Access comprehensive regulatory information for Roche Cobas aspartate aminotransferase second-generation biochemical assay reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 11d5b853d31ea8585568261a1bdfdaeb and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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11d5b853d31ea8585568261a1bdfdaeb
Registration Details
Taiwan FDA Registration: 11d5b853d31ea8585568261a1bdfdaeb
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Device Details

Roche Cobas aspartate aminotransferase second-generation biochemical assay reagent
TW: ็พ…ๆฐๅฏ้œธๆ–ฏๅคฉ้–€ๅ†ฌ้…ธๆฐจๅŸบ่ฝ‰็งป้…ถ็ฌฌไบŒไปฃ็”ŸๅŒ–ๆชข้ฉ—่ฉฆๅŠ‘
Risk Class 2

Registration Details

11d5b853d31ea8585568261a1bdfdaeb

DHA05603521007

Company Information

Germany

Product Details

This product is an in vitro diagnostic test for the quantitative detection of aspartate aminotransferase (AST) in human serum and plasma with the COBAS C 303/503/703 system (this test uses phosphopyridoxal activation).

A Clinical chemistry and clinical toxicology

A.1100 ๅคฉ้–€ๅ†ฌ่ƒบ้…ธ่ฝ‰่ƒบ้…ถ่ฉฆ้ฉ—็ณป็ตฑ

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Jan 21, 2022

Jan 21, 2027