Taiwan FDA registration 9dd32dbbd45272d53d0df23af5c1834e
Roche heart N-terminal native B-type sodium titanium test reagent
TW: 羅氏心臟N端原生B型利鈉鈦檢驗試劑
Taiwan·Risk Class 2·ROCHE DIAGNOSTICS GMBH·Registered Nov 22, 2024 – Nov 22, 2029ActiveRegistration details
- Analysis ID
- 9dd32dbbd45272d53d0df23af5c1834e
- Customs Code
- DHA05603751704
Company information
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- ROCHE DIAGNOSTICS LTD.
Product details
- Intended Use
- This product was used on the cobas h 232 analyzer for the in vitro quantitative detection of N-terminal native B-type sodium titanium (NT-proBNP) in heparinized venous blood by immunoassay.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical); A.1117 Type B diuretic lithium peptide test system
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Nov 22, 2024
- Expiry Date
- Nov 22, 2029
About this record
Access comprehensive regulatory information for Roche heart N-terminal native B-type sodium titanium test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9dd32dbbd45272d53d0df23af5c1834e and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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