Taiwan FDA registration 9858f64724a99d66407703f5470d4c63

羅氏免疫分析 EB 病毒 IgM/VCA IgG 檢驗試劑品管液

Taiwan·Risk Class 2·ROCHE DIAGNOSTICS GMBH·Registered Nov 01, 2024 – Nov 01, 2029Active

Registration details

Analysis ID: 9858f64724a99d66407703f5470d4c63
Customs Code: DHA05603750905

Company information

Manufacturer: ROCHE DIAGNOSTICS GMBH
Manufacturer Country: Germany
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: This product is used on the cobas e immunoassay for quality control of Elecsys EBV IgM and Elecsys EBV VCA IgG immunoassays.
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: QMS/QSD;; 輸入

Dates and status

Registration Date: Nov 01, 2024
Expiry Date: Nov 01, 2029

About this record

Access comprehensive regulatory information for 羅氏免疫分析 EB 病毒 IgM/VCA IgG 檢驗試劑品管液 in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9858f64724a99d66407703f5470d4c63 and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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