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"Stagnant water" Spirochelina pallidum antibody reagent quality tube solution - Taiwan Registration c73319a0e4eda587e3146ff78c08227a

Access comprehensive regulatory information for "Stagnant water" Spirochelina pallidum antibody reagent quality tube solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c73319a0e4eda587e3146ff78c08227a and manufactured by SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT. The authorized representative in Taiwan is KUO'S YUAN IN ENTERPRISE CO., LTD..

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c73319a0e4eda587e3146ff78c08227a
Registration Details
Taiwan FDA Registration: c73319a0e4eda587e3146ff78c08227a
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Device Details

"Stagnant water" Spirochelina pallidum antibody reagent quality tube solution
TW: โ€œ็ฉๆฐดโ€ ๆข…ๆฏ’่žบๆ—‹่ŒๆŠ—้ซ”่ฉฆๅŠ‘ๅ“็ฎกๆถฒ
Risk Class 2

Registration Details

c73319a0e4eda587e3146ff78c08227a

DHA05603492201

Company Information

Product Details

This product is used in an automatic biochemical analyzer to detect anti-Spirochete pallidum antibody as a special quality solution for Megaspiratus meridum antibody latex agglutination reagent.

A Clinical chemistry and clinical toxicology

A.1660 Quality control materials (analytical and non-analytical)

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Dec 15, 2021

Dec 15, 2026