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Nofacart Pertussis Bordetella enzyme immunoassay kit (unsterilized) - Taiwan Registration 01afe54d45be3b5468f23890059f2627

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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01afe54d45be3b5468f23890059f2627
Registration Details
Taiwan FDA Registration: 01afe54d45be3b5468f23890059f2627
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Device Details

Nofacart Pertussis Bordetella enzyme immunoassay kit (unsterilized)
TW: ่ซพๆณ•ๅก็‰น็™พๆ—ฅๅ’ณๅšๅพทๆฐๆกฟ่Œ้…ต็ด ๅ…็–ซๅˆ†ๆžๅฅ—็ต„(ๆœชๆป…่Œ)
Risk Class 1

Registration Details

01afe54d45be3b5468f23890059f2627

DHA04400659005

Company Information

Product Details

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.

C Immunology and microbiology

C.3065 ๅšๅพทๆฐๆกฟ่Œๅฑฌ่ก€ๆธ…่ฉฆๅŠ‘

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Mar 19, 2008

Mar 19, 2028