“Roche” cobas BKV (Non-Sterile) - Taiwan Registration d646bcd2035054aad3d7e2789c9483e6
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 d646bcd2035054aad3d7e2789c9483e6 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
d646bcd2035054aad3d7e2789c9483e6
Ministry of Health Medical Device Import No. 021190
DHA09402119008
Product Details
This product is an in vitro nucleic acid amplification test for the quantification of BK virus (BKV) DNA in human EDTA plasma. This product is intended to assist in the diagnosis and monitoring of BK virus load in transplant patients. In patients who are monitored for BK virus, viral DNA can be measured serially to assess whether treatment needs to be changed 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.
C Immunology and microbiology devices
C9999 Other
Imported from abroad
Dates and Status
Jan 15, 2020
Jan 15, 2025