Taiwan FDA registration 7a69a7cec94548b2b359625f112a17ef

Meeriel N-terminal B-type natriuretic peptide precursor testing reagent

TW: 美艾利爾N端B型利鈉肽前驅物檢驗試劑組

Taiwan·Risk Class 2·Axis-Shield Diagnostics Limited·Registered Jan 15, 2019 – Jan 15, 2029Active

Registration details

Analysis ID: 7a69a7cec94548b2b359625f112a17ef
Customs Code: DHA05603212603

Company information

Manufacturer: Axis-Shield Diagnostics Limited
Manufacturer Country: United Kingdom
Authorized Representative: Abbott Rapid Diagnostics Health Corp.

Product details

Intended Use: This product is a chemical cold particle immunoassay (CMIA), which can be used for the in vitro quantitative detection of N-terminal B-type natriuretic peptide precursors in human serum and plasma, and needs to be used with ARCHITECT iSystem with STAT standard program function.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Grade Material (Analysis Material Non-Analysis);; A.1117 Type B diuretic 鈉肽試驗系統;; A.1150 Calibrated Products
Import Information: import

Dates and status

Registration Date: Jan 15, 2019
Expiry Date: Jan 15, 2029

About this record

Access comprehensive regulatory information for Meeriel N-terminal B-type natriuretic peptide precursor testing reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7a69a7cec94548b2b359625f112a17ef and manufactured by Axis-Shield Diagnostics Limited. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..

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