Taiwan FDA registration f20f1baa5fb07b21d0f979af575559b3

Streptococcus pneumoniae urine antigen rapid diagnostic reagent (non-sterilized)

TW: 〝炬合〞肺炎鏈球菌尿液抗原快速診斷試劑(未滅菌)

Taiwan·Risk Class 1·EIKEN CHEMICAL CO., LTD. NOGI PLANT.·Registered Jun 25, 2024 – Jun 25, 2029Active

Registration details

Analysis ID: f20f1baa5fb07b21d0f979af575559b3
Customs Code: DHA09402352000

Company information

Manufacturer: EIKEN CHEMICAL CO., LTD. NOGI PLANT.
Manufacturer Country: Japan
Authorized Representative: GHOPE INTERNATIONAL BIOTECHNOLOGY CO., LTD.

Product details

Intended Use: It is limited to the first-level identification scope of streptococcus serum reagent (C.3740) in the classification and grading management measures for medical devices.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3740 鏈球菌屬血清試劑
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Jun 25, 2024
Expiry Date: Jun 25, 2029

About this record

Access comprehensive regulatory information for Streptococcus pneumoniae urine antigen rapid diagnostic reagent (non-sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number f20f1baa5fb07b21d0f979af575559b3 and manufactured by EIKEN CHEMICAL CO., LTD. NOGI PLANT.. The authorized representative in Taiwan is GHOPE INTERNATIONAL BIOTECHNOLOGY CO., LTD..

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