Taiwan FDA registration c356718a50948118e293129b2f32d532
"Bit Seal" glucose quality control solution (unsterilized)
TW: "位璽"葡萄糖品管液(未滅菌)
Registration details
- Analysis ID
- c356718a50948118e293129b2f32d532
- Customs Code
- DHA04401272705
Company information
- Manufacturer
- BIONOSTICS, INC
- Manufacturer Country
- United States
- Authorized Representative
- Bit Seal Biotechnology Co., Ltd
Product details
- Intended Use
- Limited to the first level identification range of quality control materials (analytical and non-analytical) (A.1660) of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical)
- Import Information
- import
Dates and status
- Registration Date
- Feb 21, 2013
- Expiry Date
- Feb 21, 2018
- Cancellation Date
- Dec 13, 2019
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for "Bit Seal" glucose quality control solution (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number c356718a50948118e293129b2f32d532 and manufactured by BIONOSTICS, INC. The authorized representative in Taiwan is Bit Seal Biotechnology Co., Ltd.
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