Taiwan FDA registration 6a855fa7b56bb93f8f5d24136dc96b5b

SD BIOSENSOR STANDARD F Tsutsugamushi IgM/IgG FIA (Non-Sterile)

TW: 速得百森恙蟲IgM/IgG抗體檢測試劑(未滅菌)

Taiwan·Risk Class 1·MD·SD BIOSENSOR, INC.·Registered May 25, 2022 – May 25, 2027Active

Registration details

Analysis ID: 6a855fa7b56bb93f8f5d24136dc96b5b
License Form: Ministry of Health Medical Device Import No. 022813
Customs Code: DHA09402281300

Company information

Manufacturer: SD BIOSENSOR, INC.
Manufacturer Country: Korea, Republic of
Authorized Representative: CREATIVE LIFE SCIENCE CO., LTD.

Product details

Intended Use: Limited to the classification and grading management method of medical equipment, the first level identification range of Rickettsial serum reagent (C.3500).
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C3500 rickettsial serum reagent
Import Information: Imported from abroad; GMP

Dates and status

Registration Date: May 25, 2022
Expiry Date: May 25, 2027

About this record

Access comprehensive regulatory information for SD BIOSENSOR STANDARD F Tsutsugamushi IgM/IgG FIA (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 6a855fa7b56bb93f8f5d24136dc96b5b and manufactured by SD BIOSENSOR, INC.. The authorized representative in Taiwan is CREATIVE LIFE SCIENCE CO., LTD..

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