Taiwan FDA registration c9a8b4e975a75ffc1290c026b569b5bc
NeoLSD MSMS Kit
TW: 尼奧溶小體儲積症質譜分析套組
Taiwan·Risk Class 2·MD·WALLAC OY·Registered Apr 19, 2018 – Apr 19, 2028ActiveRegistration details
- Analysis ID
- c9a8b4e975a75ffc1290c026b569b5bc
- License Form
- Ministry of Health Medical Device Import No. 030540
- Customs Code
- DHA05603054003
Company information
- Manufacturer
- WALLAC OY
- Manufacturer Country
- Finland
- Authorized Representative
- FENG CHI BIOTECH CORP.
Product details
- Intended Use
- For the quantification of acid-β-galactocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid-α-glucosidase (GAA), β-galactocerebrodidase (GALC), α-galactosidase A (GLA), α-L-iduronidase ( IDUA). Analysis of prospect enzyme activity can help neonates to screen for lysosomal storage disorder (LSD), including Gaoxue syndrome, Niemann-Pick disease, Pompe disease, Krabbe syndrome, Fabry's disease and mucopolysaccharide I.
- 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
- Apr 19, 2018
- Expiry Date
- Apr 19, 2028
About this record
Access comprehensive regulatory information for NeoLSD MSMS Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c9a8b4e975a75ffc1290c026b569b5bc and manufactured by WALLAC OY. The authorized representative in Taiwan is FENG CHI BIOTECH CORP..
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