Taiwan FDA registration 846448899684c4e3cf041320a80271a5

Roche Cobas EBV/BKV nucleic acid quality control group

TW: 羅氏可霸斯EBV/BKV核酸品管組

Taiwan·Risk Class 2·ROCHE MOLECULAR SYSTEMS, INC.·Registered Aug 03, 2021 – Aug 03, 2026Active

Registration details

Analysis ID: 846448899684c4e3cf041320a80271a5
Customs Code: DHA05603488301

Company information

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

Product details

Intended Use: 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.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical)
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Aug 03, 2021
Expiry Date: Aug 03, 2026

About this record

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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