Taiwan FDA registration 3ce96b5fc376f2bedaf446bb6e3bbcee

Leica Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor

TW: 錸卡諾摩凱斯特黃體激素受體小鼠單株抗體試劑

Taiwan·Risk Class 2·MD·LEICA BIOSYSTEMS NEWCASTLE LTD.·Registered Feb 13, 2019 – Feb 13, 2029Active

Registration details

Analysis ID: 3ce96b5fc376f2bedaf446bb6e3bbcee
License Form: Ministry of Health Medical Device Import No. 032167
Customs Code: DHA05603216704

Company information

Manufacturer: LEICA BIOSYSTEMS NEWCASTLE LTD.
Manufacturer Country: United Kingdom
Authorized Representative: BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.)

Product details

Intended Use: This product is used for in vitro diagnosis and qualitative identification of progesterone receptor molecules in formalin-fixed paraffin sections of breast tissue by light microscopy.
Product Type (Level 1): B Hematology and pathology devices
Product Type (Level 2): B1860 Immunopathological histochemical reagents and kits
Import Information: Imported from abroad

Dates and status

Registration Date: Feb 13, 2019
Expiry Date: Feb 13, 2029

About this record

Access comprehensive regulatory information for Leica Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3ce96b5fc376f2bedaf446bb6e3bbcee and manufactured by LEICA BIOSYSTEMS NEWCASTLE LTD.. The authorized representative in Taiwan is BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.).

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