Taiwan FDA registration 0425e08d558621b7c00a6f5bc6110ecc

"Jisui" Respiratory Fusion Cell Virus and Adenovirus Rapid Test Reagent (Unsterilized)

TW: "績穗" 呼吸道融合細胞病毒及腺病毒快速檢驗試劑 (未滅菌)

Taiwan·Risk Class 1·SEKISUI DIAGNOSTICS, LLC·Registered Feb 09, 2017 – Feb 09, 2027Active

Registration details

Analysis ID: 0425e08d558621b7c00a6f5bc6110ecc
Customs Code: DHA09401748104

Company information

Manufacturer: SEKISUI DIAGNOSTICS, LLC
Manufacturer Country: United States
Authorized Representative: ARSENALS IVD CO., LTD.

Product details

Intended Use: It is limited to the first-level identification scope of the "Adenovirus Serum Reagent (C.3020)" and "Respiratory Fusion Cell Virus Serum Reagent (C.3480)" in the Classification and Grading Management Measures for Medical Devices.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3480 呼吸道融合細胞病毒血清試劑;; C.3020 腺病毒血清試劑
Import Information: import

Dates and status

Registration Date: Feb 09, 2017
Expiry Date: Feb 09, 2027

About this record

Access comprehensive regulatory information for "Jisui" Respiratory Fusion Cell Virus and Adenovirus Rapid Test Reagent (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 0425e08d558621b7c00a6f5bc6110ecc and manufactured by SEKISUI DIAGNOSTICS, LLC. The authorized representative in Taiwan is ARSENALS IVD CO., LTD..

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