Taiwan FDA registration eecb83a13d829a1884030c66316d0862

"Sekisui" Strep A Rapid Test (non-sterile)

TW: "績穗" A型鏈球菌快速檢驗試劑 (未滅菌)

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

Registration details

Analysis ID: eecb83a13d829a1884030c66316d0862
License Form: Ministry of Health Medical Device Import No. 017389
Customs Code: DHA09401738903

Company information

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

Product details

Intended Use: Restriction of medical device management methods Streptococcus belongs to the first level identification range of serum reagent (C.3740).
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C3740 Streptococcus serology
Import Information: Imported from abroad

Dates and status

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

About this record

Access comprehensive regulatory information for "Sekisui" Strep A 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 eecb83a13d829a1884030c66316d0862 and manufactured by SEKISUI DIAGNOSTICS, LLC. The authorized representative in Taiwan is ARSENALS IVD CO., LTD..

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