Taiwan FDA registration a60974d3729e098edb2fcdb96ef6d025

Beckman Coulter Stem Cell Counting Reagent Group

TW: 貝克曼庫爾特幹細胞計數試劑組

Taiwan·Risk Class 2·IMMUNOTECH SAS, A BECKMAN COULTER COMPANY·Registered Jan 16, 2007 – Jan 16, 2027Active

Registration details

Analysis ID: a60974d3729e098edb2fcdb96ef6d025
Customs Code: DHA00601788400

Company information

Manufacturer: IMMUNOTECH SAS, A BECKMAN COULTER COMPANY
Manufacturer Country: France
Authorized Representative: BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.)

Product details

Intended Use: This set is suitable for in vitro diagnostics and, in conjunction with flow cytometry, can be used to simultaneously confirm and count both percentage and absolute counts of CD45-positive and CD45/CD34-positive cells in biological specimens. Biological specimens include fresh peripheral blood, standard blood cell products, umbilical cord blood, and bone marrow. Cells can be analyzed using automatic or manual circles.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.5220 Automatic Differentiation Cell Counter
Import Information: import

Dates and status

Registration Date: Jan 16, 2007
Expiry Date: Jan 16, 2027

About this record

Access comprehensive regulatory information for Beckman Coulter Stem Cell Counting Reagent Group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number a60974d3729e098edb2fcdb96ef6d025 and manufactured by IMMUNOTECH SAS, A BECKMAN COULTER COMPANY. The authorized representative in Taiwan is BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.).

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