Taiwan FDA registration 8c8e4a21f0be6481fbf03dff926da0f5

The Binding Site Rheumatoid Factor Kit for use on SPAPLUS

TW: 邦迪斯類風濕性因子分析套組

Taiwan·Risk Class 2·MD·THE BINDING SITE GROUP LTD·Registered Mar 09, 2020 – Mar 09, 2025Expired

Registration details

Analysis ID: 8c8e4a21f0be6481fbf03dff926da0f5
License Form: Ministry of Health Medical Device Import No. 033284
Customs Code: DHA05603328400

Company information

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

Product details

Intended Use: This product is used with the Binding Site SPAPLUS analyzer to quantify rheumatoid factors in serum in vitro.
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C5775 Rheumatoid factor immunoassay system
Import Information: Imported from abroad

Dates and status

Registration Date: Mar 09, 2020
Expiry Date: Mar 09, 2025

About this record

Access comprehensive regulatory information for The Binding Site Rheumatoid Factor Kit for use on SPAPLUS in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8c8e4a21f0be6481fbf03dff926da0f5 and manufactured by THE BINDING SITE GROUP LTD. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) CO., LTD..

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