Taiwan FDA registration ac89f4a5c812e94717f182489618155b
EnLite Neonatal TREC kit
TW: 恩萊新生兒T淋巴球受器剪除環檢驗套組
Taiwan·Risk Class 2·MD·WALLAC OY·Registered Nov 01, 2016 – Nov 01, 2026ActiveRegistration details
- Analysis ID
- ac89f4a5c812e94717f182489618155b
- License Form
- Ministry of Health Medical Device Import No. 028941
- Customs Code
- DHA05602894103
Company information
- Manufacturer
- WALLAC OY
- Manufacturer Country
- Finland
- Authorized Representative
- FENG CHI BIOTECH CORP.
Product details
- Intended Use
- 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.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B4020 Analyze specific reagents
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Nov 01, 2016
- Expiry Date
- Nov 01, 2026
About this record
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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