Taiwan FDA registration a34db0bb5334685489e9087e1e180dde

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 20, 2017 – Jul 20, 2027Active
Registration details
Analysis ID
a34db0bb5334685489e9087e1e180dde
Customs Code
DHA05602959706
Company information
Manufacturer Country
Germany
Authorized Representative
ROCHE DIAGNOSTICS LTD.
Product details
Intended Use
Performance (specifications 08836752190 new applicable models) changes: This product uses electrochemiluminescence immunoassay (ECLIA) with cobas e 402 and cobas e 801 immunoassay analyzers to quantitatively detect N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma in vitro.
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 20, 2017
Expiry Date
Jul 20, 2027
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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 a34db0bb5334685489e9087e1e180dde 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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