Taiwan FDA registration da63d221fde89ba93f94106d17488a17

Aspire Fecal Occult Blood Rapid Test

TW: 安速百爾糞便潛血測試劑

Taiwan·Risk Class 2·MD·FIRSTEP BIORESEARCH INC.·Registered Aug 25, 2017 – Aug 25, 2027Active

Registration details

Analysis ID: da63d221fde89ba93f94106d17488a17
License Form: Ministry of Health Medical Device Manufacturing No. 005637

Company information

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

Product details

Intended Use: This product uses immunoassay quantitative methods to quickly detect human hemoglobin (h-Hb) in feces, and interprets the results with EZquick Immunoassay Analyzer.
Product Type (Level 1): B Hematology and pathology devices
Product Type (Level 2): B6550 Occult blood test
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: Aug 25, 2017
Expiry Date: Aug 25, 2027

About this record

Access comprehensive regulatory information for Aspire Fecal Occult Blood 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 da63d221fde89ba93f94106d17488a17 and manufactured by FIRSTEP BIORESEARCH INC.. The authorized representative in Taiwan is FIRSTEP BIORESEARCH INC..

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