Taiwan FDA registration e4f4045fd35c6679667a185283c7f9f3

"Sudi" respiratory fusion cell virus rapid test reagent (unsterilized)

TW: “速帝”呼吸道融合細胞病毒快速檢驗試劑(未滅菌)

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

Registration details

Analysis ID: e4f4045fd35c6679667a185283c7f9f3
Customs Code: DHA04400908405

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 "Respiratory Fusion Cell Virus Serological Reagent (C.3480)".
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3480 呼吸道融合細胞病毒血清試劑
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 "Sudi" respiratory fusion cell virus 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 e4f4045fd35c6679667a185283c7f9f3 and manufactured by STANDARD DIAGNOSTICS, INC.. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..

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