Taiwan FDA registration 28b413d14c7424bcc692fcd40a60d1dd

Lumipulse G B‧R‧A‧H‧M‧S PCT

TW: 錄秘帕斯G前降鈣素檢驗試劑

Taiwan·Risk Class 2·MD·Fujirebio Inc. Sagamihara Facility·Registered Jan 24, 2019 – Jan 24, 2024Expired

Registration details

Analysis ID: 28b413d14c7424bcc692fcd40a60d1dd
License Form: Ministry of Health Medical Device Import No. 032148
Customs Code: DHA05603214800

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 Lumipulse G1200 to quantitatively measure calcitonin (PCT) in human serum or plasma
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C3210 Endotoxin Analysis Reagent
Import Information: Imported from abroad

Dates and status

Registration Date: Jan 24, 2019
Expiry Date: Jan 24, 2024

About this record

Access comprehensive regulatory information for Lumipulse G B‧R‧A‧H‧M‧S PCT in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 28b413d14c7424bcc692fcd40a60d1dd and manufactured by Fujirebio Inc. Sagamihara Facility. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..

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