Taiwan FDA registration d10a0760495768352d6a8db22da948e8

"Leica" Bond Ready-to-Use Primary Antibody Cytokeratin 5 (XM26)(Non-Sterile)

TW: “錸卡”邦德即用型細胞角質蛋白5一級抗體(未滅菌)

Taiwan·Risk Class 1·MD·LEICA BIOSYSTEMS NEWCASTLE LTD.·Registered Nov 26, 2018 – Nov 26, 2028Active

Registration details

Analysis ID: d10a0760495768352d6a8db22da948e8
License Form: Ministry of Health Medical Device Import No. 019851
Customs Code: DHA09401985108

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: Limited to the first level identification range of immunopathological histochemical reagents and kits (B.1860) of the Measures for the Administration of Medical Devices.
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: Nov 26, 2018
Expiry Date: Nov 26, 2028

About this record

Access comprehensive regulatory information for "Leica" Bond Ready-to-Use Primary Antibody Cytokeratin 5 (XM26)(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 d10a0760495768352d6a8db22da948e8 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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