"Fengji" neonatal creatine phosphatase MM type test kit - Taiwan Registration 244ab7f09ace9562a5bd2401a0b954cb
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..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Product Details
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.
A Clinical chemistry and clinical toxicology
A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Mar 05, 2021
Mar 05, 2026