Taiwan FDA registration 5a68b9aa6a1cf9ef60f432c8819328bf
"Arkolai" total bilirubin test strip
TW: 〝愛科來〞總膽紅素檢測試紙
Taiwan·Risk Class 2·ARKRAY Factory, Inc., Head office factory·Registered Dec 19, 2005 – Dec 19, 2025ExpiredRegistration details
- Analysis ID
- 5a68b9aa6a1cf9ef60f432c8819328bf
- Customs Code
- DHA00601568500
Company information
- Manufacturer
- ARKRAY Factory, Inc., Head office factory
- Manufacturer Country
- Japan
- Authorized Representative
- SYNGEN BIOTECH CO., LTD.
Product details
- Intended Use
- In vitro diagnostic test for total bilirubin quantification with serum or plasma, dedicated to the SPOTCHEM instrument.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1110 Bilirubin (total or direct) test system
- Import Information
- import
Dates and status
- Registration Date
- Dec 19, 2005
- Expiry Date
- Dec 19, 2025
About this record
Access comprehensive regulatory information for "Arkolai" total bilirubin 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 5a68b9aa6a1cf9ef60f432c8819328bf and manufactured by ARKRAY Factory, Inc., Head office factory. The authorized representative in Taiwan is SYNGEN BIOTECH CO., LTD..
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