Taiwan FDA registration e88a2d7c2804e6566752a17be0193dbe

Roche Cobas automatic Mycobacterium tuberculosis detection reagent

TW: 羅氏可霸斯全自動結核桿菌檢測試劑

Taiwan·Risk Class 3·Roche Molecular Systems, Inc.;; ROCHE DIAGNOSTICS GMBH·Registered Dec 18, 2019 – Dec 18, 2029Active

Registration details

Analysis ID: e88a2d7c2804e6566752a17be0193dbe
Customs Code: DHA05603311302

Company information

Manufacturer: Roche Molecular Systems, Inc.;; ROCHE DIAGNOSTICS GMBH
Manufacturer Country: United States;;Germany
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: The change efficiency (new applicable models) is: detailed as the approved version of the Chinese manual.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.4020 Analysis of specific tests
Import Information: Input;; Contract manufacturing

Dates and status

Registration Date: Dec 18, 2019
Expiry Date: Dec 18, 2029

About this record

Access comprehensive regulatory information for Roche Cobas automatic Mycobacterium tuberculosis detection reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number e88a2d7c2804e6566752a17be0193dbe and manufactured by Roche Molecular Systems, Inc.;; ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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