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"Eprocex" anti-K blood group reagent (monoclonal antibody) (IgG) - Taiwan Registration c9112a63e1acb27a594fa2495a18bbe6

Access comprehensive regulatory information for "Eprocex" anti-K blood group reagent (monoclonal antibody) (IgG) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c9112a63e1acb27a594fa2495a18bbe6 and manufactured by IMMUCOR, INC.. The authorized representative in Taiwan is Y.H. BIOTEK CO., LTD..

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c9112a63e1acb27a594fa2495a18bbe6
Registration Details
Taiwan FDA Registration: c9112a63e1acb27a594fa2495a18bbe6
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Device Details

"Eprocex" anti-K blood group reagent (monoclonal antibody) (IgG)
TW: โ€œไพๅ…ๅฏโ€ๆŠ—k่ก€ๅž‹่ฉฆๅŠ‘(ๅ–ฎๆ ชๆŠ—้ซ”)(IgG)
Risk Class 2

Registration Details

c9112a63e1acb27a594fa2495a18bbe6

DHA05603418200

Company Information

United States

Product Details

This product uses indirect agglutination to detect k (KEL2) antigen on red blood cells.

B Hematology, pathology, and genetics

B.4020 Analysis of specific tests

Input;; QMS/QSD

Dates and Status

Dec 30, 2020

Dec 30, 2025