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Abbott second generation amylase assay set - Taiwan Registration 00305bc1691f3b327b29bfa6bb8ad150

Access comprehensive regulatory information for Abbott second generation amylase assay set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 00305bc1691f3b327b29bfa6bb8ad150 and manufactured by ABBOTT IRELAND DIAGNOSTICS DIVISION. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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00305bc1691f3b327b29bfa6bb8ad150
Registration Details
Taiwan FDA Registration: 00305bc1691f3b327b29bfa6bb8ad150
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Device Details

Abbott second generation amylase assay set
TW: ไบžๅŸน็ฌฌไบŒไปฃๆพฑ็ฒ‰้…ถๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

00305bc1691f3b327b29bfa6bb8ad150

DHA05603491909

Company Information

Product Details

This product is used to quantify amylase in human serum, plasma or urine on the Alinity c System.

A Clinical chemistry and clinical toxicology

A.1070 ๆพฑ็ฒ‰้…ถ่ฉฆ้ฉ—็ณป็ตฑ

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Dec 09, 2021

Dec 09, 2026