Taiwan FDA registration 05944257c994b10778a87254c92cae8c

羅氏免疫分析 EB 病毒 EB 核抗原抗體 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: 05944257c994b10778a87254c92cae8c
Customs Code: DHA05603751003

Company information

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

Product details

Intended Use: This product is used in the cobas e immunoassay for quality control of Elecsys EBV EBNA IgG immunoassay method.
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: Input;; QMS/QSD

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 EB 核抗原抗體 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 05944257c994b10778a87254c92cae8c and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.