Taiwan FDA registration f06ed25eee1d5090d9defeaecf8c599a
"Fengji" biotin enzyme deficiency test kit
TW: “豐技”生物素酵素缺乏症檢測套組
Registration details
- Analysis ID
- f06ed25eee1d5090d9defeaecf8c599a
- Customs Code
- DHA05603326601
Company information
- Manufacturer
- WALLAC OY
- Manufacturer Country
- Finland
- Authorized Representative
- FENG CHI BIOTECH CORP.
Product details
- Intended Use
- This product is used with GSP system to quantify the activity of biotin enzyme in neonatal heel blood film samples, which is helpful for screening newborns with biotin enzyme deficiency.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1118 Biotinenzyme testing system
- Import Information
- import
Dates and status
- Registration Date
- Feb 05, 2020
- Expiry Date
- Feb 05, 2030
About this record
Access comprehensive regulatory information for "Fengji" biotin enzyme deficiency test kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f06ed25eee1d5090d9defeaecf8c599a and manufactured by WALLAC OY. The authorized representative in Taiwan is FENG CHI BIOTECH CORP..
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