Taiwan FDA registration 01afe54d45be3b5468f23890059f2627

Nofacart Pertussis Bordetella enzyme immunoassay kit (unsterilized)

TW: 諾法卡特百日咳博德氏桿菌酵素免疫分析套組(未滅菌)

Taiwan·Risk Class 1·GOLD STANDARD DIAGNOSTICS FRANKFURT GMBH·Registered Mar 19, 2008 – Mar 19, 2028Active

Registration details

Analysis ID: 01afe54d45be3b5468f23890059f2627
Customs Code: DHA04400659005

Company information

Manufacturer: GOLD STANDARD DIAGNOSTICS FRANKFURT GMBH
Manufacturer Country: Germany
Authorized Representative: EVERLIGHT BIOTECH(TAIWAN) CO., LTD.

Product details

Intended Use: It is limited to the first level of identification of Borde's serum reagent (C.3065) in the Administrative Measures for the Classification and Grading of Medical Devices.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3065 博德氏桿菌屬血清試劑
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Mar 19, 2008
Expiry Date: Mar 19, 2028

About this record

Access comprehensive regulatory information for Nofacart Pertussis Bordetella enzyme immunoassay kit (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 01afe54d45be3b5468f23890059f2627 and manufactured by GOLD STANDARD DIAGNOSTICS FRANKFURT GMBH. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) CO., LTD..

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