Taiwan FDA registration d1378676922ad4e282d48c886c8f5723
"Will get" Streptococcus pneumoniae rapid fluorescence enzyme immunoassay test kit (unsterilized)
TW: "會得" 舒妃雅肺炎鏈球菌快速螢光酵素免疫分析檢測套組 (未滅菌)
Taiwan·Risk Class 1·QUIDEL CORPORATION·Registered Feb 01, 2023 – Feb 01, 2028ActiveRegistration details
- Analysis ID
- d1378676922ad4e282d48c886c8f5723
- Customs Code
- DHA09402302901
Company information
- Manufacturer
- QUIDEL CORPORATION
- Manufacturer Country
- United States
- Authorized Representative
- GRAND MARQUIS CO., LTD.
Product details
- Intended Use
- Classification and grading management method of medical equipment: Streptococcus belongs to the first level identification range of serum reagent (C.3740).
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3740 鏈球菌屬血清試劑
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Feb 01, 2023
- Expiry Date
- Feb 01, 2028
About this record
Access comprehensive regulatory information for "Will get" Streptococcus pneumoniae rapid fluorescence enzyme immunoassay test 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 d1378676922ad4e282d48c886c8f5723 and manufactured by QUIDEL CORPORATION. The authorized representative in Taiwan is GRAND MARQUIS CO., LTD..
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