Taiwan FDA registration cce65416cb91691a0c1d9c149a46d0ea
The Binding Site Hevylite Human IgM Kappa Kit
TW: 邦迪斯卡巴型人類免疫球蛋白M輕鏈分析套組
Taiwan·Risk Class 2·MD·THE BINDING SITE GROUP LTD·Registered May 25, 2018 – May 25, 2023ExpiredRegistration details
- Analysis ID
- cce65416cb91691a0c1d9c149a46d0ea
- License Form
- Ministry of Health Medical Device Import No. 031126
- Customs Code
- DHA05603112601
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 a SPAPLUS analyzer to quantify carba-type immunoglobulin M (IgM kappa) in human serum.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C5510 Immunoglobulins A, G, M, D and E Immunoassay System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- May 25, 2018
- Expiry Date
- May 25, 2023
About this record
Access comprehensive regulatory information for The Binding Site Hevylite Human IgM Kappa Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number cce65416cb91691a0c1d9c149a46d0ea and manufactured by THE BINDING SITE GROUP LTD. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) CO., LTD..
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