Taiwan FDA registration 540ef3ca420038d6eb79180f02fd4600
Shiji 5801 test kit
TW: 世基5801檢測套組
Taiwan·Risk Class 2·Shiji Biomedical Co., Ltd. Taipei Plant·Registered Jan 10, 2011 – Jan 10, 2026ExpiredRegistration details
- Analysis ID
- 540ef3ca420038d6eb79180f02fd4600
- Customs Code
- DHY00500320502
Company information
- Manufacturer
- Shiji Biomedical Co., Ltd. Taipei Plant
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- PHARMIGENE, INC.
Product details
- Intended Use
- The HLA-B*5801 gene was qualitatively detected by real-time polymerase chain reaction technology.
- 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
- Jan 10, 2011
- Expiry Date
- Jan 10, 2026
About this record
Access comprehensive regulatory information for Shiji 5801 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 540ef3ca420038d6eb79180f02fd4600 and manufactured by Shiji Biomedical Co., Ltd. Taipei Plant. The authorized representative in Taiwan is PHARMIGENE, INC..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI89,000+ Devices