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Beckman Coulter Flow-Count Fluorospheres - Taiwan Registration 95b397a3c78e39c3409ba02d7fb80dd0

Access comprehensive regulatory information for Beckman Coulter Flow-Count Fluorospheres in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 95b397a3c78e39c3409ba02d7fb80dd0 and manufactured by Beckman Coulter, Inc.. The authorized representative in Taiwan is BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.).

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95b397a3c78e39c3409ba02d7fb80dd0
Registration Details
Taiwan FDA Registration: 95b397a3c78e39c3409ba02d7fb80dd0
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Device Details

Beckman Coulter Flow-Count Fluorospheres
TW: ่ฒๅ…‹ๆ›ผๅบซ็ˆพ็‰นๆตฎ็พ…ๅบท่žขๅ…‰็ƒ
Risk Class 2
MD

Registration Details

95b397a3c78e39c3409ba02d7fb80dd0

Ministry of Health Medical Device Import No. 030507

DHA05603050705

Company Information

United States

Product Details

This product is a fluorescent sphere (fluorescent microsphere) reagent for the direct determination of lymphocytes. Percentage and absolute counts of lymphocyte subsets in biological samples were detected using EPICS XL/XL-MCL, Cytomics FC 500, Navios and Navios EX flow cytometry systems and cell counting systems. Analyze CD34+ cell population percentages and absolute counts in biological samples using EPICS XL/XL-MCL and Cytomics FC5 flow cytometry systems.

B Hematology and pathology devices

B5220 automatically differentiates cell counters

Imported from abroad

Dates and Status

Feb 21, 2018

Feb 21, 2028