Taiwan FDA registration c81666a73f0a197163c4dcbe54570a45

Himosir Weberland factor lyase activity reagent

TW: 希摩西爾魏伯蘭特因子裂解酶活性試劑

Taiwan·Risk Class 2·INSTRUMENTATION LABORATORY CO.;; BIOKIT S.A.·Registered May 08, 2023 – May 08, 2028Active

Registration details

Analysis ID: c81666a73f0a197163c4dcbe54570a45
Customs Code: DHA05603617408

Company information

Manufacturer: INSTRUMENTATION LABORATORY CO.;; BIOKIT S.A.
Manufacturer Country: Spain;;United States
Authorized Representative: Werfen Taiwan Limited

Product details

Intended Use: This product is used with Bio-Flash instrument to quantitatively measure ADAMTS13 activity in human 3.2% or 3.8% citrate acidated plasma with fully automated chemiluminescence immunoassay (CIA). This assay is intended for use by professionals.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.7290 factor deficiency test
Import Information: 輸入;; QMS/QSD;; 委託製造

Dates and status

Registration Date: May 08, 2023
Expiry Date: May 08, 2028

About this record

Access comprehensive regulatory information for Himosir Weberland factor lyase activity reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c81666a73f0a197163c4dcbe54570a45 and manufactured by INSTRUMENTATION LABORATORY CO.;; BIOKIT S.A.. The authorized representative in Taiwan is Werfen Taiwan Limited.

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