Taiwan FDA registration 348673407d0818691ec026da7f8c3616

"Abbot" Helicobacter pylori antigen rapid diagnostic reagent (unsterilized)

TW: "亞培" 百而靈幽門螺旋桿菌抗原快速診斷試劑(未滅菌)

Taiwan·Risk Class 1·ABBOTT DIAGNOSTICS KOREA INC.·Registered Jun 15, 2010 – Jun 15, 2025Expired

Registration details

Analysis ID: 348673407d0818691ec026da7f8c3616
Customs Code: DHA04400891201

Company information

Manufacturer: ABBOTT DIAGNOSTICS KOREA INC.
Manufacturer Country: Korea, Republic of
Authorized Representative: Abbott Rapid Diagnostics Health Corp.

Product details

Intended Use: Limited to the classification and grading management of medical devices, the first level identification range of "Helicobacter serum reagent (C.0003)".
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.0003 螺旋桿菌屬血清試劑
Import Information: import

Dates and status

Registration Date: Jun 15, 2010
Expiry Date: Jun 15, 2025

About this record

Access comprehensive regulatory information for "Abbot" Helicobacter pylori antigen rapid diagnostic reagent (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 348673407d0818691ec026da7f8c3616 and manufactured by ABBOTT DIAGNOSTICS KOREA INC.. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.