Taiwan FDA registration ddef3fa5dd6048a32a358adacba70cd4

Roche Cobas HSV 1 and 2 assays

TW: 羅氏可霸斯HSV 1和2檢驗試劑

Taiwan·Risk Class 2·ROCHE MOLECULAR SYSTEMS, INC.·Registered Jun 22, 2015 – Jun 22, 2025Expired

Registration details

Analysis ID: ddef3fa5dd6048a32a358adacba70cd4
Customs Code: DHA05602735600

Company information

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

Product details

Intended Use: The Roche Cobas HSV 1 and 2 assays performed on the cobas 4800 system are automated, qualitative in vitro diagnostic tests. This test uses real-time PCR to directly detect and type herpes simplex virus types 1 and 2 (HSV-I and HSV-2) DNA in samples of anogenital lesions taken by clinicians from symptomatic male and female patients. The purpose of the Roche Cabas HSV 1 and 2 tests is to assist in the diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3305 Seroanalysis of monoperiasis virus
Import Information: import

Dates and status

Registration Date: Jun 22, 2015
Expiry Date: Jun 22, 2025

About this record

Access comprehensive regulatory information for Roche Cobas HSV 1 and 2 assays in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ddef3fa5dd6048a32a358adacba70cd4 and manufactured by ROCHE MOLECULAR SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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