Taiwan FDA registration 244ab7f09ace9562a5bd2401a0b954cb
"Fengji" neonatal creatine phosphatase MM type test kit
TW: “豐技” 新生兒肌酸磷酸酵素MM型檢測套組
Taiwan·Risk Class 2·WALLAC OY·Registered Mar 05, 2021 – Mar 05, 2026ExpiredRegistration details
- Analysis ID
- 244ab7f09ace9562a5bd2401a0b954cb
- Customs Code
- DHA05603436900
Company information
- Manufacturer
- WALLAC OY
- Manufacturer Country
- Finland
- Authorized Representative
- FENG CHI BIOTECH CORP.
Product details
- Intended Use
- This product can be used with GSP system to quantify creatine phosphatase MM concentration (CK-MM) in dried filter paper blood films to screen for neonatal Duchenne Muscular Dystrophy DMD. This product cannot be used to diagnose DMD disease, and cannot be used to screen for other types of muscular insufficiency or female DMD disease carriers.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Mar 05, 2021
- Expiry Date
- Mar 05, 2026
About this record
Access comprehensive regulatory information for "Fengji" neonatal creatine phosphatase MM type 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 244ab7f09ace9562a5bd2401a0b954cb and manufactured by WALLAC OY. The authorized representative in Taiwan is FENG CHI BIOTECH CORP..
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