Taiwan FDA registration 5cb082b40f8c419b20d9ec4bb5d7bac8

Roche Cobas fully automated Mycobacterium tuberculosis RIF/INH resistance gene test reagent

TW: 羅氏可霸斯全自動結核桿菌RIF/INH抗藥基因檢驗試劑
Taiwan flagTaiwan·Risk Class 2·Roche Molecular Systems, Inc.;; ROCHE DIAGNOSTICS GMBH·Registered Apr 27, 2021 – Apr 27, 2026Expired
Registration details
Analysis ID
5cb082b40f8c419b20d9ec4bb5d7bac8
Customs Code
DHA05603463600
Company information
Manufacturer Country
United States;;Germany
Authorized Representative
ROCHE DIAGNOSTICS LTD.
Product details
Intended Use
For details, please refer to the approved version of the Chinese manual.
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.1640 抗菌感受性試驗粉末
Import Information
委託製造;; QMS/QSD;; 輸入
Dates and status
Registration Date
Apr 27, 2021
Expiry Date
Apr 27, 2026
About this record

Access comprehensive regulatory information for Roche Cobas fully automated Mycobacterium tuberculosis RIF/INH resistance gene test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5cb082b40f8c419b20d9ec4bb5d7bac8 and manufactured by Roche Molecular Systems, Inc.;; ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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