Taiwan FDA registration 6f01eb2cbb929773de6cbeb715f24e18
"Arkra" starch hydrolytic enzyme test strip
TW: "愛科來" 澱粉水解酵素檢測試紙
Registration details
- Analysis ID
- 6f01eb2cbb929773de6cbeb715f24e18
- Customs Code
- DHA00601572509
Company information
- Manufacturer
- ARKRAY Factory, Inc., Head office factory
- Manufacturer Country
- Japan
- Authorized Representative
- SYNGEN BIOTECH CO., LTD.
Product details
- Intended Use
- SPOTCHEM II Amylase is an in vitro diagnostic test used in serum or plasma for the quantitative determination of Amylase, which is dedicated to SPOTCHEM instruments.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1070 澱粉酶試驗系統
- Import Information
- import
Dates and status
- Registration Date
- Dec 22, 2005
- Expiry Date
- Dec 22, 2025
About this record
Access comprehensive regulatory information for "Arkra" starch hydrolytic enzyme test strip in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6f01eb2cbb929773de6cbeb715f24e18 and manufactured by ARKRAY Factory, Inc., Head office factory. The authorized representative in Taiwan is SYNGEN BIOTECH CO., LTD..
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