Taiwan FDA registration b6e7fb00a0c73c16237d811bcb7b06ee
"Shiji" whole blood nucleic acid extraction kit (unsterilized)
TW: "世基" 全血核酸萃取套組 (未滅菌)
Registration details
- Analysis ID
- b6e7fb00a0c73c16237d811bcb7b06ee
Company information
- Manufacturer
- Shiji Biomedical Co., Ltd. Xizhi Factory
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- PHARMIGENE, INC.
Product details
- Intended Use
- Limited to the first level identification scope of "General Purpose Reaction Reagents (B.4010)" under the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.4010 Reaction Reagents for General Purposes
- Import Information
- Domestic
Dates and status
- Registration Date
- Apr 20, 2011
- Expiry Date
- Apr 20, 2016
- Cancellation Date
- Aug 14, 2018
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for "Shiji" whole blood nucleic acid extraction kit (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b6e7fb00a0c73c16237d811bcb7b06ee and manufactured by Shiji Biomedical Co., Ltd. Xizhi Factory. The authorized representative in Taiwan is PHARMIGENE, INC..
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