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Roche Cobas fully automated Mycobacterium tuberculosis RIF/INH resistance gene test reagent - Taiwan Registration 5cb082b40f8c419b20d9ec4bb5d7bac8

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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5cb082b40f8c419b20d9ec4bb5d7bac8
Registration Details
Taiwan FDA Registration: 5cb082b40f8c419b20d9ec4bb5d7bac8
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Device Details

Roche Cobas fully automated Mycobacterium tuberculosis RIF/INH resistance gene test reagent
TW: ็พ…ๆฐๅฏ้œธๆ–ฏๅ…จ่‡ชๅ‹•็ตๆ ธๆกฟ่ŒRIF/INHๆŠ—่—ฅๅŸบๅ› ๆชข้ฉ—่ฉฆๅŠ‘
Risk Class 2

Registration Details

5cb082b40f8c419b20d9ec4bb5d7bac8

DHA05603463600

Company Information

Product Details

For details, please refer to the approved version of the Chinese manual.

C Immunology and microbiology

C.1640 ๆŠ—่Œๆ„Ÿๅ—ๆ€ง่ฉฆ้ฉ—็ฒ‰ๆœซ

ๅง”่จ—่ฃฝ้€ ;; QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Apr 27, 2021

Apr 27, 2026