Roche Cobas HSV 1 and 2 assays - Taiwan Registration ddef3fa5dd6048a32a358adacba70cd4
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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Device Details
Product Details
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.
C Immunology and microbiology
C.3305 Seroanalysis of monoperiasis virus
import
Dates and Status
Jun 22, 2015
Jun 22, 2025