Taiwan FDA registration 7170c19ce391511c1e784f3c3c6f97e0
Speed Test New blood glucose/uric acid monitoring system
TW: 耐速測 全新 血糖/尿酸 監測系統
Taiwan·Risk Class 2·BIOPTIK TECHNOLOGY, INC.·Registered Jun 14, 2018 – Jun 14, 2028ActiveRegistration details
- Analysis ID
- 7170c19ce391511c1e784f3c3c6f97e0
Company information
- Manufacturer
- BIOPTIK TECHNOLOGY, INC.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- KERNEL INT'L CORP.
Product details
- Intended Use
- This product is only for in vitro testing to quantitatively measure blood glucose and uric acid levels using fresh fingertip microvascular whole blood. This product is intended for self-testing and professional use, but is not intended for testing in newborns.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1775 Uric acid testing system;; A.1345 Glucose Test System
- Import Information
- Contract manufacturing;; Domestic
Dates and status
- Registration Date
- Jun 14, 2018
- Expiry Date
- Jun 14, 2028
About this record
Access comprehensive regulatory information for Speed Test New blood glucose/uric acid monitoring system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7170c19ce391511c1e784f3c3c6f97e0 and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is KERNEL INT'L CORP..
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