Taiwan FDA registration 18d2bfd14a6fc9c1bb4206a794c0ef9c

Roche Cobas HIV type 1 viral weight nucleic acid testing group

TW: 羅氏可霸斯愛滋病毒第一型病毒量核酸檢驗組

Taiwan·Risk Class 3·Roche Molecular Systems, Inc.;; ROCHE DIAGNOSTICS GMBH·Registered Mar 23, 2017 – Mar 23, 2027Active

Registration details

Analysis ID: 18d2bfd14a6fc9c1bb4206a794c0ef9c
Customs Code: DHA05602951708

Company information

Manufacturer: Roche Molecular Systems, Inc.;; ROCHE DIAGNOSTICS GMBH
Manufacturer Country: United States;;Germany
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 type 1.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.4020 Analysis of specific tests
Import Information: Input;; Contract manufacturing

Dates and status

Registration Date: Mar 23, 2017
Expiry Date: Mar 23, 2027

About this record

Access comprehensive regulatory information for Roche Cobas HIV type 1 viral weight 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 18d2bfd14a6fc9c1bb4206a794c0ef9c and manufactured by Roche Molecular Systems, Inc.;; ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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