Taiwan FDA registration 7399b1b57d544a20d7883fbe0f250aec
Optilite Freelite Mx Kappa Free Kit
TW: 歐普羅自由輕鏈米克斯人類卡巴試劑套組
Taiwan·Risk Class 2·MD·THE BINDING SITE GROUP LTD·Registered Jan 24, 2019 – Jan 24, 2029ActiveRegistration details
- Analysis ID
- 7399b1b57d544a20d7883fbe0f250aec
- License Form
- Ministry of Health Medical Device Import No. 032145
- Customs Code
- DHA05603214507
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 an in vitro diagnostic reagent with "Taiyang" Opro optimized protein analysis system for the quantitative determination of k free light chain in vitro, suitable for plasma, urine or CSF (cerebrospinal fluid) with serum, heparin lithium salt and EDTA as anticoagulants.
- 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
- Jan 24, 2019
- Expiry Date
- Jan 24, 2029
About this record
Access comprehensive regulatory information for Optilite Freelite Mx Kappa Free Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7399b1b57d544a20d7883fbe0f250aec and manufactured by THE BINDING SITE GROUP LTD. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) CO., LTD..
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