Taiwan FDA registration 3ddd396bd281287e6198c4c9ab86b096
"Shiji" Tissue Nucleic Acid Extraction Kit (Unsterilized)
TW: "世基" 組織核酸萃取套組 (未滅菌)
Registration details
- Analysis ID
- 3ddd396bd281287e6198c4c9ab86b096
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" Tissue 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 3ddd396bd281287e6198c4c9ab86b096 and manufactured by Shiji Biomedical Co., Ltd. Xizhi Factory. The authorized representative in Taiwan is PHARMIGENE, INC..
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