Taiwan FDA registration fa0c35af9ca9f1475a4eaa9d81c48fa9

"Audi" Mycobacterium tuberculosis antigen rapid test reagent (unsterilized)　

TW: "歐帝" 結核桿菌抗原快速檢驗試劑 (未滅菌)　

Taiwan·Risk Class 1·ALL. DIAG·Registered Sep 18, 2012 – Sep 18, 2017Cancelled

Registration details

Analysis ID: fa0c35af9ca9f1475a4eaa9d81c48fa9
Customs Code: DHA04401217801

Company information

Manufacturer: ALL. DIAG
Manufacturer Country: France
Authorized Representative: DYBO ENTERPRISE COMPANY LIMITED

Product details

Intended Use: Limited to the first level identification range of Mycobacterium tuberculosis immunofluorescent reagent (C.3370) of the management method for medical devices.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3370 結核桿菌免疫螢光試劑
Import Information: import

Dates and status

Registration Date: Sep 18, 2012
Expiry Date: Sep 18, 2017
Cancellation Date: Nov 26, 2019

Cancellation information

Status: Logged out
Reason: 未展延而逾期者

About this record

Access comprehensive regulatory information for "Audi" Mycobacterium tuberculosis antigen rapid test 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 fa0c35af9ca9f1475a4eaa9d81c48fa9 and manufactured by ALL. DIAG. The authorized representative in Taiwan is DYBO ENTERPRISE COMPANY LIMITED.

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.