Taiwan FDA registration 70ef78b2ce651c637fa955c194423de7
Shiji 1075 test kit
TW: 世基1075檢測套組
Taiwan·Risk Class 2·Shiji Biomedical Co., Ltd. Taipei Plant·Registered May 05, 2010 – May 05, 2030ActiveRegistration details
- Analysis ID
- 70ef78b2ce651c637fa955c194423de7
- Customs Code
- DHY00500304404
Company information
- Manufacturer
- Shiji Biomedical Co., Ltd. Taipei Plant
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- PHARMIGENE, INC.
Product details
- Intended Use
- The Shiji 1075 Nucleic Acid Molecular Detection Kit used real-time polymerase chain reaction technology to analyze the genotype of CYP2C9*3 c.1075 A>C SNP in biological samples.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.3360 Genotype testing system for drug metabolic enzymes
- Import Information
- Domestic
Dates and status
- Registration Date
- May 05, 2010
- Expiry Date
- May 05, 2030
About this record
Access comprehensive regulatory information for Shiji 1075 test kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 70ef78b2ce651c637fa955c194423de7 and manufactured by Shiji Biomedical Co., Ltd. Taipei Plant. The authorized representative in Taiwan is PHARMIGENE, INC..
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