Taiwan FDA registration 260d6e16bffc5659f4898f5c6064eb87

"Sekisui" Flu A&B Rapid Test (Non-Sterile)

TW: "績穗" A+B型流行性感冒快速檢驗試劑 (未滅菌)

Taiwan·Risk Class 1·MD·SEKISUI DIAGNOSTICS, LLC·Registered Jan 09, 2017 – Jan 09, 2022Expired

Registration details

Analysis ID: 260d6e16bffc5659f4898f5c6064eb87
License Form: Ministry of Health Medical Device Import No. 017390
Customs Code: DHA09401739001

Company information

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

Product details

Intended Use: Limited to the first level identification range of the Measures for the Administration of Medical Devices "Influenza Virus Serum Reagent (C.3330)".
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C3330 Influenza virus serum reagent
Import Information: Imported from abroad

Dates and status

Registration Date: Jan 09, 2017
Expiry Date: Jan 09, 2022

About this record

Access comprehensive regulatory information for "Sekisui" Flu A&B Rapid Test (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 260d6e16bffc5659f4898f5c6064eb87 and manufactured by SEKISUI DIAGNOSTICS, LLC. The authorized representative in Taiwan is ARSENALS IVD CO., LTD..

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