Taiwan FDA registration b759eb0a83a114f8f5eb72775b7e3924
Lumipulse G HBcrAg
TW: 錄秘帕斯Ｇ Ｂ型肝炎病毒核心關連抗原檢驗試劑
Taiwan·Risk Class 3·MD·Fujirebio Inc. Sagamihara Facility·Registered Mar 14, 2019 – Mar 14, 2024ExpiredRegistration details
- Analysis ID
- b759eb0a83a114f8f5eb72775b7e3924
- License Form
- Ministry of Health Medical Device Import No. 032374
- Customs Code
- DHA05603237409
Company information
- Manufacturer
- Fujirebio Inc. Sagamihara Facility
- Manufacturer Country
- Japan
- Authorized Representative
- Grand Marquis IVD CO., LTD.
Product details
- Intended Use
- This product is used with the G1200 system to quantitatively measure hepatitis B virus core-related antigen (HBcrAg) in human serum or plasma.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B4020 Analyze specific reagents
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Mar 14, 2019
- Expiry Date
- Mar 14, 2024
About this record
Access comprehensive regulatory information for Lumipulse G HBcrAg in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number b759eb0a83a114f8f5eb72775b7e3924 and manufactured by Fujirebio Inc. Sagamihara Facility. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..
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