Taiwan FDA registration 454b4e51faeca273ee17ec4a997dd715

Bondis Human Beta-2 Microsphere Protein Detection Kit

TW: 邦迪斯人類Beta-2微球蛋白質檢測套組

Taiwan·Risk Class 2·THE BINDING SITE GROUP LIMITED·Registered Jan 19, 2012 – Jan 19, 2027Active

Registration details

Analysis ID: 454b4e51faeca273ee17ec4a997dd715
Customs Code: DHA00602309409

Company information

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

Product details

Intended Use: The purpose of this set is to quantify beta-2 microsphere protein in human serum and urine in vitro, and the operation platform is SPAPLUS analyzer, and the results obtained in this set can be applied to assist in the clinical diagnosis of rheumatoid arthritis and kidney disease in the active phase. The analysis results of this set must be combined with other clinical manifestations and other laboratory analysis results, and cannot be used as the only reference for clinical laboratories based on the analysis results of this set alone.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.5630 β-2-微球蛋白免疫試驗系統
Import Information: import

Dates and status

Registration Date: Jan 19, 2012
Expiry Date: Jan 19, 2027

About this record

Access comprehensive regulatory information for Bondis Human Beta-2 Microsphere Protein Detection Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 454b4e51faeca273ee17ec4a997dd715 and manufactured by THE BINDING SITE GROUP LIMITED. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) CO., LTD..

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