Taiwan FDA registration 5c9602183e88d75f6bf25717f0198af4

BECKMAN COULTER UniCel DxI 800 Access Immunoassay System (Non-Sterile)

TW: 貝克曼庫爾特 UniCel DxI 800 亞瑟斯免疫分析系統(未滅菌)

Taiwan·Risk Class 1·MD·BECKMAN COULTER INC.·Registered Oct 01, 2021 – Oct 31, 2025Expired

Registration details

Analysis ID: 5c9602183e88d75f6bf25717f0198af4
License Form: Ministry of Health Medical Device Import Registration No. 000997
Customs Code: DHA08400099702

Company information

Manufacturer: BECKMAN COULTER INC.
Manufacturer Country: United States
Authorized Representative: BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.)

Product details

Intended Use: 1. UniCel DxI 800 Arthurs immunoassay system provides clinical laboratory to perform automated quantitative analysis of serum immunology in vitro diagnosis, Arthurs immunoassay system provides routine serum immunology examination items including hormonal test, thyroid test, anemia test, heart test, infection source test and cancer test. 2. UniCel DxI800 Arthurs Wash Buffer is designed for the Access Immunoassay System and Access Immunoassay Reagents.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A2160 Individual photometric chemistry analyzer for clinical use
Import Information: Imported from abroad

Dates and status

Registration Date: Oct 01, 2021
Expiry Date: Oct 31, 2025

About this record

Access comprehensive regulatory information for BECKMAN COULTER UniCel DxI 800 Access Immunoassay System (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 5c9602183e88d75f6bf25717f0198af4 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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