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Lumipulse G HBsAg-Quant Confirmation - Taiwan Registration 47d427b81a1dcc03281fc5ca60d7f177

Access comprehensive regulatory information for Lumipulse G HBsAg-Quant Confirmation in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 47d427b81a1dcc03281fc5ca60d7f177 and manufactured by FUJIREBIO INC., HACHIOJI FACILITY. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..

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47d427b81a1dcc03281fc5ca60d7f177
Registration Details
Taiwan FDA Registration: 47d427b81a1dcc03281fc5ca60d7f177
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Device Details

Lumipulse G HBsAg-Quant Confirmation
TW: ้Œ„็ฅ•ๅธ•ๆ–ฏGBๅž‹่‚็‚Ž็—…ๆฏ’่กจ้ขๆŠ—ๅŽŸ็ขบ่ช่ฉฆๅŠ‘
Risk Class 3
MD

Registration Details

47d427b81a1dcc03281fc5ca60d7f177

Ministry of Health Medical Device Import No. 031403

DHA05603140301

Company Information

Product Details

This product is a confirmation reagent for the quantitative test reagent of hepatitis B virus surface antigen in the recording of the Pas GB hepatitis virus surface antigen quantitative test reagent, which is used to confirm the existence of human serum or plasma hepatitis B surface antigen (HBsAg).

B Hematology and pathology devices

B4020 Analyze specific reagents

Imported from abroad

Dates and Status

Aug 07, 2018

Aug 07, 2023