Taiwan FDA registration 6dd0f25781c6de0967193c8256cb8bf4

“EUROIMMUN” Anti-Phoshatidylserine ELISA (IgG)

TW: “歐蒙” 免疫酵素法抗磷脂醯絲胺酸IgG抗體試劑

Taiwan·Risk Class 2·MD·EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·Registered Dec 07, 2017 – Dec 07, 2027Active

Registration details

Analysis ID: 6dd0f25781c6de0967193c8256cb8bf4
License Form: Ministry of Health Medical Device Import No. 030467
Customs Code: DHA05603046706

Company information

Manufacturer: EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG
Manufacturer Country: Germany
Authorized Representative: EUROIMMUN (SOUTH EAST ASIA) PTE. LTD. TAIWAN BRANCH (SINGAPORE)

Product details

Intended Use: This product is used for the semi-quantitative or quantitative detection of antiphosphatidylserine antibody immunoglobulin G (IgG) in human serum or plasma in vitro to assist in the diagnosis of antiphospholipid syndrome.
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C5660 Multiple autologous antibody immunoassay system
Import Information: Imported from abroad

Dates and status

Registration Date: Dec 07, 2017
Expiry Date: Dec 07, 2027

About this record

Access comprehensive regulatory information for “EUROIMMUN” Anti-Phoshatidylserine ELISA (IgG) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6dd0f25781c6de0967193c8256cb8bf4 and manufactured by EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG. The authorized representative in Taiwan is EUROIMMUN (SOUTH EAST ASIA) PTE. LTD. TAIWAN BRANCH (SINGAPORE).

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