Taiwan FDA registration a8a1fa703441b657e043f6d3748ba5e5

Speedi Rotavirus Rapid Test Reagent (Unsterilized)

TW: “速帝”輪狀病毒快速檢驗試劑 (未滅菌)

Taiwan·Risk Class 1·STANDARD DIAGNOSTICS, INC.·Registered Aug 12, 2010 – Aug 12, 2020Cancelled

Registration details

Analysis ID: a8a1fa703441b657e043f6d3748ba5e5
Customs Code: DHA04400908507

Company information

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

Product details

Intended Use: Limited to the first level identification range of the Measures for the Administration of Medical Devices "Polio Virus Serological Reagent (C.3405)".
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3405 Poliomyelitis virus serum reagent
Import Information: import

Dates and status

Registration Date: Aug 12, 2010
Expiry Date: Aug 12, 2020
Cancellation Date: Jul 15, 2022

Cancellation information

Status: Logged out
Reason: 未展延而逾期者

About this record

Access comprehensive regulatory information for Speedi Rotavirus 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 a8a1fa703441b657e043f6d3748ba5e5 and manufactured by STANDARD DIAGNOSTICS, 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.