“Roche” cobas BKV (Non-Sterile) - Taiwan Registration 8a55972153768444a43b670e56625dea
Access comprehensive regulatory information for “Roche” cobas BKV (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 8a55972153768444a43b670e56625dea and manufactured by Roche Molecular Systems, Inc.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Roche Molecular Systems, Inc., and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
8a55972153768444a43b670e56625dea
Ministry of Health Medical Device Import No. 022021
DHA09402202103
Product Details
This product is an in vitro nucleic acid amplification test for the quantification of BK virus (BKV) DNA in human EDTA plasma and cobas PCR media-fixed urine samples. This product is intended to assist in the diagnosis and monitoring of BK virus load in transplant patients. When used in EDTA plasma, viral DNA can be measured serially in patients under BK virus surveillance to assess the need for treatment changes and to assess the response of the virus to treatment. The results of this test must be evaluated in conjunction with other relevant clinical and laboratory findings. This product is not intended for screening of blood or blood products.
C Immunology and microbiology devices
C9999 Other
Imported from abroad
Dates and Status
Oct 13, 2020
Oct 13, 2025