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"E-Exempt" Anti-Fya Blood Group Reagent (monochronic antibody) - Taiwan Registration 15b2adbaaafd8f061150d89748995d6d

Access comprehensive regulatory information for "E-Exempt" Anti-Fya Blood Group Reagent (monochronic antibody) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 15b2adbaaafd8f061150d89748995d6d and manufactured by IMMUCOR, INC.. The authorized representative in Taiwan is Y.H. BIOTEK CO., LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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15b2adbaaafd8f061150d89748995d6d
Registration Details
Taiwan FDA Registration: 15b2adbaaafd8f061150d89748995d6d
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Device Details

"E-Exempt" Anti-Fya Blood Group Reagent (monochronic antibody)
TW: โ€œไพๅ…ๅฏโ€ ๆŠ—Fya่ก€ๅž‹่ฉฆๅŠ‘(ๅ–ฎๆ ชๆŠ—้ซ”)
Risk Class 2

Registration Details

15b2adbaaafd8f061150d89748995d6d

DHA05602752408

Company Information

United States

Product Details

This product uses an indirect antiglobulin test tube method to detect Fya(FY1) antigen on red blood cells.

B Hematology, pathology, and genetics

B.4020 Analysis of specific tests

import

Dates and Status

Jul 17, 2015

Jul 17, 2025