Taiwan FDA registration c73319a0e4eda587e3146ff78c08227a

"Stagnant water" Spirochelina pallidum antibody reagent quality tube solution

TW: “積水” 梅毒螺旋菌抗體試劑品管液

Taiwan·Risk Class 2·SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT·Registered Dec 15, 2021 – Dec 15, 2026Active

Registration details

Analysis ID: c73319a0e4eda587e3146ff78c08227a
Customs Code: DHA05603492201

Company information

Manufacturer: SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT
Manufacturer Country: Japan
Authorized Representative: KUO'S YUAN IN ENTERPRISE CO., LTD.

Product details

Intended Use: 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.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical)
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Dec 15, 2021
Expiry Date: Dec 15, 2026

About this record

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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