Taiwan FDA registration aab7daea80f14ae3d643b947af9a15b3
Shiji 1502 test kit
TW: 世基1502 檢測套組
Taiwan·Risk Class 2·Shiji Biomedical Co., Ltd. Taipei Plant·Registered Feb 24, 2009 – Jul 01, 2028ActiveRegistration details
- Analysis ID
- aab7daea80f14ae3d643b947af9a15b3
- Customs Code
- DHY00500258800
Company information
- Manufacturer
- Shiji Biomedical Co., Ltd. Taipei Plant
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- PHARMIGENE, INC.
Product details
- Intended Use
- The PG-1502 Nucleic Acid Molecular Detection Kit qualitatively detects HLA-B*1502 gene by real-time polymerase chain reaction.
- 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 24, 2009
- Expiry Date
- Jul 01, 2028
About this record
Access comprehensive regulatory information for Shiji 1502 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 aab7daea80f14ae3d643b947af9a15b3 and manufactured by Shiji Biomedical Co., Ltd. Taipei Plant. The authorized representative in Taiwan is PHARMIGENE, INC..
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