Taiwan FDA registration 8fa54bdd8d756db83c32e03cd776d8ed

The Binding Site FREELITE Human Kappa Free Kit For use on the Roche cobas c systems

TW: 邦迪斯自由輕鏈人類卡巴試劑套組

Taiwan·Risk Class 2·MD·THE BINDING SITE GROUP LIMITED·Registered Dec 02, 2013 – Dec 02, 2023Expired

Registration details

Analysis ID: 8fa54bdd8d756db83c32e03cd776d8ed
License Form: Ministry of Health Medical Device Import No. 025564
Customs Code: DHA05602556400

Company information

Manufacturer: THE BINDING SITE GROUP LIMITED
Manufacturer Country: United Kingdom
Authorized Representative: EVERLIGHT BIOTECH(TAIWAN) CO., LTD.

Product details

Intended Use: This kit was used in conjunction with the C 501 module of the Roche Cobas C 6000 series and the C 502 module of the Roche Cobas C 8000 series for the quantitative analysis of free Kappa light chains in serum.
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C5550 Immunoglobulin (Specific Light Chain) Immunoassay System
Import Information: Imported from abroad

Dates and status

Registration Date: Dec 02, 2013
Expiry Date: Dec 02, 2023

About this record

Access comprehensive regulatory information for The Binding Site FREELITE Human Kappa Free Kit For use on the Roche cobas c systems in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8fa54bdd8d756db83c32e03cd776d8ed and manufactured by THE BINDING SITE GROUP LIMITED. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) CO., LTD..

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