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Lumipulse G HBcrAg - Taiwan Registration b759eb0a83a114f8f5eb72775b7e3924

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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b759eb0a83a114f8f5eb72775b7e3924
Registration Details
Taiwan FDA Registration: b759eb0a83a114f8f5eb72775b7e3924
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Device Details

Lumipulse G HBcrAg
TW: ้Œ„็ง˜ๅธ•ๆ–ฏ๏ผงใ€€๏ผขๅž‹่‚็‚Ž็—…ๆฏ’ๆ ธๅฟƒ้—œ้€ฃๆŠ—ๅŽŸๆชข้ฉ—่ฉฆๅŠ‘
Risk Class 3
MD

Registration Details

b759eb0a83a114f8f5eb72775b7e3924

Ministry of Health Medical Device Import No. 032374

DHA05603237409

Company Information

Product Details

This product is used with the G1200 system to quantitatively measure hepatitis B virus core-related antigen (HBcrAg) in human serum or plasma.

B Hematology and pathology devices

B4020 Analyze specific reagents

Imported from abroad

Dates and Status

Mar 14, 2019

Mar 14, 2024