Taiwan FDA registration 3ab5907796bfac0f2c6f098289f6597b

"Exempt" automated hemotyping analyzer

TW: “依免可”自動血液分型分析儀

Taiwan·Risk Class 2·IMMUCOR, INC.·Registered Apr 26, 2012 – Apr 26, 2027Active

Registration details

Analysis ID: 3ab5907796bfac0f2c6f098289f6597b
Customs Code: DHA00602346202

Company information

Manufacturer: IMMUCOR, INC.
Manufacturer Country: United States
Authorized Representative: Y.H. BIOTEK CO., LTD.

Product details

Intended Use: The microprocessor control system is used to automatically perform blood immunological analysis, and the test items can be performed, including ABO and Rh blood group analysis, red blood cell IgG antibody detection/identification, pre-transfusion synthesis and red blood cell phenotyping test.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.9175 Automated Blood Classification and Antibody Testing System
Import Information: import

Dates and status

Registration Date: Apr 26, 2012
Expiry Date: Apr 26, 2027

About this record

Access comprehensive regulatory information for "Exempt" automated hemotyping analyzer in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3ab5907796bfac0f2c6f098289f6597b and manufactured by IMMUCOR, INC.. The authorized representative in Taiwan is Y.H. BIOTEK CO., LTD..

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