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“Ortho” DAT/IDAT cassette - Taiwan Registration dbba860c9323a5f1cc963c3249b1b307

Access comprehensive regulatory information for “Ortho” DAT/IDAT cassette in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number dbba860c9323a5f1cc963c3249b1b307 and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..

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dbba860c9323a5f1cc963c3249b1b307
Registration Details
Taiwan FDA Registration: dbba860c9323a5f1cc963c3249b1b307
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Device Details

“Ortho” DAT/IDAT cassette
TW: “奧索” 拜而優系統(直接抗球蛋白試驗/間接抗球蛋白試驗卡片)
Risk Class 2
MD

Registration Details

dbba860c9323a5f1cc963c3249b1b307

Ministry of Health Medical Device Import No. 027688

DHA05602768802

Company Information

United Kingdom

Product Details

Qualitative detection of immunoglobulins or complement bound to red blood cells (anti-IgG and anti-C3b, anti-C3d).

B Hematology and pathology devices

B9175 Automated Blood Sorting and Antibody Testing System

Imported from abroad

Dates and Status

Sep 21, 2015

Sep 21, 2025