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EnLite Neonatal TREC kit - Taiwan Registration ac89f4a5c812e94717f182489618155b

Access comprehensive regulatory information for EnLite Neonatal TREC kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ac89f4a5c812e94717f182489618155b and manufactured by WALLAC OY. The authorized representative in Taiwan is FENG CHI BIOTECH CORP..

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ac89f4a5c812e94717f182489618155b
Registration Details
Taiwan FDA Registration: ac89f4a5c812e94717f182489618155b
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Device Details

EnLite Neonatal TREC kit
TW: ๆฉ่Šๆ–ฐ็”Ÿๅ…’Tๆท‹ๅทด็ƒๅ—ๅ™จๅ‰ช้™ค็’ฐๆชข้ฉ—ๅฅ—็ต„
Risk Class 2
MD

Registration Details

ac89f4a5c812e94717f182489618155b

Ministry of Health Medical Device Import No. 028941

DHA05602894103

Company Information

Finland

Product Details

This product is used for the quantitative detection of T-cell receptor excision circle (TREC) concentration in neonatal screening filter blood films, and is used for neonatal screening for severe combined immunodeficiency (SCID). Analysis using polymerase chain reaction in conjunction with the VICTOR EnLite fluorescence instrument.

B Hematology and pathology devices

B4020 Analyze specific reagents

Imported from abroad

Dates and Status

Nov 01, 2016

Nov 01, 2026