Taiwan FDA registration 3748b1e99abde9584e4e274475458abb

碁米庫斯克雷伯氏肺炎桿菌K1/K2 血清分型抗原檢驗試劑 (未滅菌)

Taiwan·Risk Class 1·Wuding Biotechnology Co., Ltd. Taoyuan No.2 Factory;; Thermocous Biotechnology Co., Ltd·Registered Aug 20, 2024 – Aug 20, 2029Active

Registration details

Analysis ID: 3748b1e99abde9584e4e274475458abb

Company information

Manufacturer: Wuding Biotechnology Co., Ltd. Taoyuan No.2 Factory;; Thermocous Biotechnology Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: KEMYTH BIOTECH CO., LTD.

Product details

Intended Use: Limited to the first level of identification of Klebsiella serum reagent (C.3340) in the Measures for the Classification and Grading of Medical Devices.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3340 克雷白氏桿菌屬血清試劑
Import Information: 委託製造;; 國產;; QMS/QSD

Dates and status

Registration Date: Aug 20, 2024
Expiry Date: Aug 20, 2029

About this record

Access comprehensive regulatory information for 碁米庫斯克雷伯氏肺炎桿菌K1/K2 血清分型抗原檢驗試劑 (未滅菌) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 3748b1e99abde9584e4e274475458abb and manufactured by Wuding Biotechnology Co., Ltd. Taoyuan No.2 Factory;; Thermocous Biotechnology Co., Ltd. The authorized representative in Taiwan is KEMYTH BIOTECH CO., LTD..

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