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Roche Cobas EBV/BKV nucleic acid quality control group - Taiwan Registration 846448899684c4e3cf041320a80271a5

Access comprehensive regulatory information for Roche Cobas EBV/BKV nucleic acid quality control group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 846448899684c4e3cf041320a80271a5 and manufactured by ROCHE MOLECULAR SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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846448899684c4e3cf041320a80271a5
Registration Details
Taiwan FDA Registration: 846448899684c4e3cf041320a80271a5
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Device Details

Roche Cobas EBV/BKV nucleic acid quality control group
TW: ็พ…ๆฐๅฏ้œธๆ–ฏEBV/BKVๆ ธ้…ธๅ“็ฎก็ต„
Risk Class 2

Registration Details

846448899684c4e3cf041320a80271a5

DHA05603488301

Company Information

United States

Product Details

This product is a positive quality control solution for the cobas 6800/8800 system with cobas BKV and cobas EBV test reagents. Efficacy (specification 09040951190) change: This product is a positive quality control solution used in the cobas 5800/6800/8800 system with cobas BKV and cobas EBV test reagents.

A Clinical chemistry and clinical toxicology

A.1660 Quality control materials (analytical and non-analytical)

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Aug 03, 2021

Aug 03, 2026