Taiwan FDA registration 5b4240d0f259748481601a147731832d

Wuding glycated hemoglobin reagent cassette

TW: 五鼎糖化血色素試劑卡匣

Taiwan·Risk Class 2·APEX BIOTECHNOLOGY CORPORATION·Registered Nov 02, 2023 – Nov 02, 2028Active

Registration details

Analysis ID: 5b4240d0f259748481601a147731832d

Company information

Manufacturer: APEX BIOTECHNOLOGY CORPORATION
Manufacturer Country: Taiwan, Province of China
Authorized Representative: APEX BIOTECHNOLOGY CORPORATION

Product details

Intended Use: This product is used with a Wuding 4-in-1 multi-function analyzer to quantitatively detect the concentration of glycosylated hemoglobin (HbA1c) in fingertip microvascular whole blood or venous whole blood.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.7470 Analysis of glycosylated hemoglobin
Import Information: 國產;; QMS/QSD

Dates and status

Registration Date: Nov 02, 2023
Expiry Date: Nov 02, 2028

About this record

Access comprehensive regulatory information for Wuding glycated hemoglobin reagent cassette in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5b4240d0f259748481601a147731832d and manufactured by APEX BIOTECHNOLOGY CORPORATION. The authorized representative in Taiwan is APEX BIOTECHNOLOGY CORPORATION.

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