Taiwan FDA registration 7b49312bec86177cf0b7598123a1a176
Shiji 1639 test kit
TW: 世基1639檢測套組
Taiwan·Risk Class 2·Shiji Biomedical Co., Ltd. Taipei Plant·Registered Feb 11, 2010 – Feb 11, 2030ActiveRegistration details
- Analysis ID
- 7b49312bec86177cf0b7598123a1a176
- Customs Code
- DHY00500302806
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 1639 Nucleic Acid Molecular Detection Kit used real-time polymerase chain reaction technology to analyze the genotype of VKORC1-1639 G>A 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
- Feb 11, 2010
- Expiry Date
- Feb 11, 2030
About this record
Access comprehensive regulatory information for Shiji 1639 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 7b49312bec86177cf0b7598123a1a176 and manufactured by Shiji Biomedical Co., Ltd. Taipei Plant. The authorized representative in Taiwan is PHARMIGENE, INC..
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