Taiwan FDA registration 44d5d15d1eb867126a49fb34a37fef62

Thermocil thirteenth coagulation factor antigen reagent

TW: 希摩西爾第十三凝固因子抗原試劑

Taiwan·Risk Class 2·INSTRUMENTATION LABORATORY CO.;; BIOKIT S.A.·Registered Nov 29, 2012 – Nov 29, 2027Active

Registration details

Analysis ID: 44d5d15d1eb867126a49fb34a37fef62
Customs Code: DHA00602412907

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 equipped with IL blood coagulation instrument system, using latex immunoassay to quantify the antigen concentration of thirteenth coagulation factor in citrate plasma.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.7290 factor deficiency test
Import Information: import

Dates and status

Registration Date: Nov 29, 2012
Expiry Date: Nov 29, 2027

About this record

Access comprehensive regulatory information for Thermocil thirteenth coagulation factor antigen reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 44d5d15d1eb867126a49fb34a37fef62 and manufactured by INSTRUMENTATION LABORATORY CO.;; BIOKIT S.A.. The authorized representative in Taiwan is Werfen Taiwan Limited.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.