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Beckman Coulter ClearLLab Reagents - Taiwan Registration 5ab3a7aa48bd9f66cbcf5db117ba68b1

Access comprehensive regulatory information for Beckman Coulter ClearLLab Reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5ab3a7aa48bd9f66cbcf5db117ba68b1 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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5ab3a7aa48bd9f66cbcf5db117ba68b1
Registration Details
Taiwan FDA Registration: 5ab3a7aa48bd9f66cbcf5db117ba68b1
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Device Details

Beckman Coulter ClearLLab Reagents
TW: ่ฒๅ…‹ๆ›ผๅบซ็ˆพ็‰นๅ…็–ซๅˆ†ๅž‹่ฉฆๅŠ‘
Risk Class 2
MD

Registration Details

5ab3a7aa48bd9f66cbcf5db117ba68b1

Ministry of Health Medical Device Import No. 031346

DHA05603134602

Company Information

United States

Product Details

This product is an in vitro diagnostic reagent that can identify various cell populations by immunotyping on the FC500 flow cytometer. This product is designed to assist in the differential diagnosis of types of hematologic abnormalities in patients with or suspected hematopoietic cell carcinogenesis, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN). This reagent can be used for immunotyping of peripheral whole blood (K2EDTA, ACD, or Heparin), bone marrow (K2EDTA, ACD, or Heparin), and lymph node samples.

B Hematology and pathology devices

B5220 automatically differentiates cell counters

Imported from abroad

Dates and Status

Aug 03, 2018

Aug 03, 2028