Taiwan FDA registration 50b22136e2c1ea7b69b5f3281e23c789

Neonatal amino acids and acylcarnitine non-derivatization assay sets of Neonatal Amino Acids and Acylcarnitine Assay Kits

TW: 尼奧貝斯2新生兒胺基酸與醯基肉鹼非衍生法測定套組

Taiwan·Risk Class 2·WALLAC OY·Registered May 31, 2019 – May 31, 2029Active

Registration details

Analysis ID: 50b22136e2c1ea7b69b5f3281e23c789
Customs Code: DHA05603244200

Company information

Manufacturer: WALLAC OY
Manufacturer Country: Finland
Authorized Representative: FENG CHI BIOTECH CORP.

Product details

Intended Use: Cooperate with tandem mass spectrometry to analyze and evaluate the concentration of amino acids, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid in neonatal heel blood film samples. The quantitative analysis of these analytes and their correlation provide the concentration of each analyte and can also aid in the screening of neonatal metabolic diseases.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1055 新生兒胺基acid、游離肉鹼及醯基肉鹼篩檢用串聯質譜儀系統
Import Information: import

Dates and status

Registration Date: May 31, 2019
Expiry Date: May 31, 2029

About this record

Access comprehensive regulatory information for Neonatal amino acids and acylcarnitine non-derivatization assay sets of Neonatal Amino Acids and Acylcarnitine Assay Kits in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 50b22136e2c1ea7b69b5f3281e23c789 and manufactured by WALLAC OY. The authorized representative in Taiwan is FENG CHI BIOTECH CORP..

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