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Beckman Coulter Treponema pallidum latex reagent group - Taiwan Registration da86ebd80ea4df97d854b361cf8cda56

Access comprehensive regulatory information for Beckman Coulter Treponema pallidum latex reagent group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number da86ebd80ea4df97d854b361cf8cda56 and manufactured by SENTINEL CH. SPA. The authorized representative in Taiwan is BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.).

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da86ebd80ea4df97d854b361cf8cda56
Registration Details
Taiwan FDA Registration: da86ebd80ea4df97d854b361cf8cda56
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Device Details

Beckman Coulter Treponema pallidum latex reagent group
TW: ่ฒๅ…‹ๆ›ผๅบซ็ˆพ็‰นๆข…ๆฏ’่žบๆ—‹้ซ”ไนณ่† ่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

da86ebd80ea4df97d854b361cf8cda56

DHA05603314002

Company Information

Product Details

This product is an in vitro diagnostic reagent, by immunoturbidimetry, using AU analyzer to determine anti-treponemal (TP) antibodies in serum and heparin lithium or EDTA plasma.

A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology

A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration;; C.3830 Treponema pallidum test

import

Dates and Status

Feb 03, 2020

Feb 03, 2030