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Lumipulse HBcrAg Controls - Taiwan Registration 4216aed55f43c13cfd775b8e6b8ea811

Access comprehensive regulatory information for Lumipulse HBcrAg Controls in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4216aed55f43c13cfd775b8e6b8ea811 and manufactured by FUJIREBIO INC., HACHIOJI FACILITY. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..

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4216aed55f43c13cfd775b8e6b8ea811
Registration Details
Taiwan FDA Registration: 4216aed55f43c13cfd775b8e6b8ea811
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Device Details

Lumipulse HBcrAg Controls
TW: ้Œ„็ง˜ๅธ•ๆ–ฏBๅž‹่‚็‚Ž็—…ๆฏ’ๆ ธๅฟƒ้—œ้€ฃๆŠ—ๅŽŸๅ“็ฎกๆถฒ
Risk Class 2
MD

Registration Details

4216aed55f43c13cfd775b8e6b8ea811

Ministry of Health Medical Device Import No. 031477

DHA05603147701

Company Information

Product Details

This product is used for the quality control of Hepatitis B virus core-related antigen (HBcrAg) by the Paz G system.

A Clinical chemistry and clinical toxicology

A1660 Quality Control Materials (Analytical and Non-Analytical)

Imported from abroad

Dates and Status

Sep 26, 2018

Sep 26, 2028