Taiwan FDA registration 244e75f499de5916f024839a4b25b288

Roche Cobas fully automated HIV virometric nucleic acid testing group

TW: 羅氏可霸斯全自動愛滋病毒第一型病毒量核酸檢驗組

Taiwan·Risk Class 3·ROCHE MOLECULAR SYSTEMS, INC.·Registered May 03, 2018 – May 03, 2028Active

Registration details

Analysis ID: 244e75f499de5916f024839a4b25b288
Customs Code: DHA05603110200

Company information

Manufacturer: ROCHE MOLECULAR SYSTEMS, INC.
Manufacturer Country: United States
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: This product can be used to quantify the amount of HIV-1 virus in EDTA plasma of patients infected with Human Immunodeficiency Virus Type 1 (HIV-1).
Product Type (Level 1): B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical); B.4020 Analysis of specific tests
Import Information: import

Dates and status

Registration Date: May 03, 2018
Expiry Date: May 03, 2028

About this record

Access comprehensive regulatory information for Roche Cobas fully automated HIV virometric nucleic acid testing group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 244e75f499de5916f024839a4b25b288 and manufactured by ROCHE MOLECULAR SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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