Taiwan FDA registration 79dcfc36ef195752a95aea14fea0c1a5

Freelite Human Kappa Free Kit for use on the MININEPHPLUS

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 Jul 14, 2014 – Jul 14, 2024Expired

Registration details

Analysis ID: 79dcfc36ef195752a95aea14fea0c1a5
License Form: Ministry of Health Medical Device Import No. 026266
Customs Code: DHA05602626607

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 IS USED TO QUANTIFY CARBA FREE LIGHT CHAINS IN HUMAN SERUM AND IS USED WITH A MININEPHPLUS ANALYZER.
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: Jul 14, 2014
Expiry Date: Jul 14, 2024

About this record

Access comprehensive regulatory information for Freelite Human Kappa Free Kit for use on the MININEPHPLUS in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 79dcfc36ef195752a95aea14fea0c1a5 and manufactured by THE BINDING SITE GROUP LIMITED. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) CO., LTD..

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