Taiwan FDA registration 028069574f01ae9da6918013116f5846

Roche Cobas human negative plasma quality control group

TW: 羅氏可霸斯人類陰性血漿品管組

Taiwan·Risk Class 2·ROCHE MOLECULAR SYSTEMS, INC.·Registered May 11, 2022 – May 11, 2027Active

Registration details

Analysis ID: 028069574f01ae9da6918013116f5846
Customs Code: DHA05603524500

Company information

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

Product details

Intended Use: This product is used in the human negative plasma control group of the COBAS 5800/6800/8800 system with the test reagent for the analysis of human blood samples.
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: Input;; QMS/QSD

Dates and status

Registration Date: May 11, 2022
Expiry Date: May 11, 2027

About this record

Access comprehensive regulatory information for Roche Cobas human negative plasma 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 028069574f01ae9da6918013116f5846 and manufactured by ROCHE MOLECULAR SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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