Taiwan FDA registration 9a0e7bf23cc035199b7292b3039e21e1

"Siemens" human immunodeficiency virus genotyping kit

TW: “西門子”人類免疫不全病毒基因分型套組

Taiwan·Risk Class 2·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Registered Oct 13, 2011 – Oct 13, 2016Cancelled

Registration details

Analysis ID: 9a0e7bf23cc035199b7292b3039e21e1
Customs Code: DHA00602272908

Company information

Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Country: United States
Authorized Representative: SIEMENS LIMITED

Product details

Intended Use: Paired with the OpenGene DNA Sequencing System for the analysis of HIV gene mutations in specific classes of antiretroviral drugs that are resistant to HIV infection, to assist in the monitoring and treatment of HIV infection.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.4020 Analysis of specific tests
Import Information: import

Dates and status

Registration Date: Oct 13, 2011
Expiry Date: Oct 13, 2016
Cancellation Date: Jul 31, 2018

Cancellation information

Status: Logged out
Reason: 未展延而逾期者

About this record

Access comprehensive regulatory information for "Siemens" human immunodeficiency virus genotyping kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9a0e7bf23cc035199b7292b3039e21e1 and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC.. The authorized representative in Taiwan is SIEMENS LIMITED.

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