Taiwan FDA registration 15b2adbaaafd8f061150d89748995d6d

"E-Exempt" Anti-Fya Blood Group Reagent (monochronic antibody)

TW: “依免可” 抗Fya血型試劑(單株抗體)
Taiwan flagTaiwan·Risk Class 2·IMMUCOR, INC.·Registered Jul 17, 2015 – Jul 17, 2025Expired
Registration details
Analysis ID
15b2adbaaafd8f061150d89748995d6d
Customs Code
DHA05602752408
Company information
Manufacturer
IMMUCOR, INC.
Manufacturer Country
United States
Authorized Representative
Y.H. BIOTEK CO., LTD.
Product details
Intended Use
This product uses an indirect antiglobulin test tube method to detect Fya(FY1) antigen on red blood cells.
Product Type (Level 1)
B Hematology, pathology, and genetics
Product Type (Level 2)
B.4020 Analysis of specific tests
Import Information
import
Dates and status
Registration Date
Jul 17, 2015
Expiry Date
Jul 17, 2025
About this record

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..

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