Taiwan FDA registration b7760178990f96874b7436f4d8b5dddd
錄秘帕斯 G 異常凝血酶原-N 檢驗試劑
Taiwan·Risk Class 2·Fujirebio Inc. Sagamihara Facility·Registered Dec 07, 2023 – Dec 07, 2028ActiveRegistration details
- Analysis ID
- b7760178990f96874b7436f4d8b5dddd
- Customs Code
- DHA05603624100
Company information
- Manufacturer
- Fujirebio Inc. Sagamihara Facility
- Manufacturer Country
- Japan
- Authorized Representative
- Grand Marquis IVD CO., LTD.
Product details
- Intended Use
- Quantitatively measured abnormal prothrombin (PIVKA-II) in human serum or plasma with the Phospas G system to assist in the diagnosis of hepatocellular carcinoma.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.6010 腫瘤相關抗原免疫試驗系統
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Dec 07, 2023
- Expiry Date
- Dec 07, 2028
About this record
Access comprehensive regulatory information for 錄秘帕斯 G 異常凝血酶原-N 檢驗試劑 in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b7760178990f96874b7436f4d8b5dddd and manufactured by Fujirebio Inc. Sagamihara Facility. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..
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