Taiwan FDA registration a7441bbe1466ef76774d012b2857d99e

"Roche" Cobax fully automated nontuberculous mycobacterial nucleic acid test group (unsterilized)

TW: "羅氏" 可霸斯全自動非結核分枝桿菌核酸檢驗組(未滅菌)
Taiwan flagTaiwan·Risk Class 1·Roche Molecular Systems, Inc.;; ROCHE DIAGNOSTICS GMBH·Registered Feb 27, 2020 – Feb 27, 2030Active
Registration details
Analysis ID
a7441bbe1466ef76774d012b2857d99e
Customs Code
DHA09402132202
Company information
Manufacturer Country
United States;;Germany
Authorized Representative
ROCHE DIAGNOSTICS LTD.
Product details
Intended Use
Limited to the classification and grading management method of medical equipment, Mycobacterium tuberculosis immunofluorescent reagent (C.3370) first level identification range.
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.3370 結核桿菌免疫螢光試劑
Import Information
輸入;; QMS/QSD;; 委託製造
Dates and status
Registration Date
Feb 27, 2020
Expiry Date
Feb 27, 2030
About this record

Access comprehensive regulatory information for "Roche" Cobax fully automated nontuberculous mycobacterial nucleic acid test group (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number a7441bbe1466ef76774d012b2857d99e and manufactured by Roche Molecular Systems, Inc.;; ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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