Taiwan FDA registration a4c17cb0b9105925c5161da8cf0e1321

Aspire Syphilis Rapid test

TW: 安速百爾梅毒螺旋體抗體試劑

Taiwan·Risk Class 2·MD·FIRSTEP BIORESEARCH INC.·Registered Dec 14, 2016 – Dec 14, 2026Active

Registration details

Analysis ID: a4c17cb0b9105925c5161da8cf0e1321
License Form: Ministry of Health Medical Device Manufacturing No. 005358

Company information

Manufacturer: FIRSTEP BIORESEARCH INC.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: FIRSTEP BIORESEARCH INC.

Product details

Intended Use: This reagent is used by immunochromatography to qualitatively detect antibodies in human serum, plasma or whole blood against Treponema pallidum, a bacterium that causes syphilis infection. This test can be used to assist in the detection of treponemal antibodies in infected individuals.
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C3830 Treponema pallidum reagent
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: Dec 14, 2016
Expiry Date: Dec 14, 2026

About this record

Access comprehensive regulatory information for Aspire Syphilis Rapid test in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number a4c17cb0b9105925c5161da8cf0e1321 and manufactured by FIRSTEP BIORESEARCH INC.. The authorized representative in Taiwan is FIRSTEP BIORESEARCH INC..

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