Taiwan FDA registration 076771454884a304ece989a8a827d3e6

Roche immunoassay B-type natriuretic peptide precursor assay second generation

TW: 羅氏免疫分析B型利鈉肽前驅物檢驗試劑第二代
Taiwan flagTaiwan·Risk Class 2·ROCHE DIAGNOSTICS GMBH·Registered Jul 24, 2013 – Jul 24, 2023Expired
Registration details
Analysis ID
076771454884a304ece989a8a827d3e6
Customs Code
DHA05602509501
Company information
Manufacturer Country
Germany
Authorized Representative
ROCHE DIAGNOSTICS LTD.
Product details
Intended Use
This product is suitable for Elecsys 2010, MODULAR ANALYTICS E170, COBAS e 411/601/602 immunoassay, using electrochemiluminescence immunoassay (ECLIA) to quantitatively detect N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1150 校正品;; A.1117 B型利尿鈉肽試驗系統
Import Information
import
Dates and status
Registration Date
Jul 24, 2013
Expiry Date
Jul 24, 2023
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About this record

Access comprehensive regulatory information for Roche immunoassay B-type natriuretic peptide precursor assay second generation in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 076771454884a304ece989a8a827d3e6 and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including ROCHE DIAGNOSTICS GMBH, and 2 recent registrations in the same category. 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.

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