Taiwan FDA registration 2da2925e531a64ba59b285e1cfcb0ac2

Innolarich glycolipid reagent tray

TW: 伊諾來富糖脂試劑盤

Taiwan·Risk Class 2·PROTECTLIFE INTERNATIONAL BIOMEDICAL INC.·Registered Sep 23, 2024 – Sep 23, 2029Active

Registration details

Analysis ID: 2da2925e531a64ba59b285e1cfcb0ac2

Company information

Manufacturer: PROTECTLIFE INTERNATIONAL BIOMEDICAL INC.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: PROTECTLIFE INTERNATIONAL BIOMEDICAL INC.

Product details

Intended Use: 本產品係一專用於伊諾來富臨床化學分析儀 (ENNOLIFE Clinical Chemistry Analyzer) 之一次性體外檢驗產品,其原理是利用乾式及濕式試劑反應達到定量檢測總膽固醇 (TC)、三酸甘油脂 (TG) 及葡萄糖 (GLU) 濃度的目標,適用的樣本包括成年者之人類肝素鋰抗凝全血 (lithium heparinized whole blood)、肝素鋰抗凝血漿 (lithium heparinized plasma)、肝素鋰抗凝指尖全血(lithium heparinized fingertip whole blood) 或血清 (serum).
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1345 Glucose Test System;; A.1705 Triglyceride test system;; A.1175 Cholesterol (Total) Testing System
Import Information: 國產;; QMS/QSD

Dates and status

Registration Date: Sep 23, 2024
Expiry Date: Sep 23, 2029

About this record

Access comprehensive regulatory information for Innolarich glycolipid reagent tray in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 2da2925e531a64ba59b285e1cfcb0ac2 and manufactured by PROTECTLIFE INTERNATIONAL BIOMEDICAL INC.. The authorized representative in Taiwan is PROTECTLIFE INTERNATIONAL BIOMEDICAL INC..

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