Taiwan FDA registration 767f46d315abbe2cf275f8aabff5a4a5

"Asian Genes" Rotavirus Antigen Rapid Test (Unsterilized)

TW: “亞洲基因” 輪狀病毒抗原快速檢測試劑(未滅菌)

Taiwan·Risk Class 1·Asia Gene Technology Co., Ltd. Shanhua Factory·Registered Aug 07, 2023 – Aug 07, 2028Active

Registration details

Analysis ID: 767f46d315abbe2cf275f8aabff5a4a5

Company information

Manufacturer: Asia Gene Technology Co., Ltd. Shanhua Factory
Manufacturer Country: Taiwan, Province of China
Authorized Representative: Asia Gene Technology Co., Ltd. Shanhua Factory

Product details

Intended Use: Limited to the classification and grading management of medical equipment, "Polio virus serum reagent (C.3405)" and "microbial sample collection and delivery equipment (C.2900)" level 1 identification range.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3405 Serum test for poliovirus;; C.2900 Microbial sample collection and delivery equipment
Import Information: QMS/QSD;; 國產

Dates and status

Registration Date: Aug 07, 2023
Expiry Date: Aug 07, 2028

About this record

Access comprehensive regulatory information for "Asian Genes" Rotavirus Antigen Rapid Test (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 767f46d315abbe2cf275f8aabff5a4a5 and manufactured by Asia Gene Technology Co., Ltd. Shanhua Factory. The authorized representative in Taiwan is Asia Gene Technology Co., Ltd. Shanhua Factory.

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