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“EUROIMMUN” Anti-Phoshatidylserine ELISA (IgG) - Taiwan Registration 6dd0f25781c6de0967193c8256cb8bf4

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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6dd0f25781c6de0967193c8256cb8bf4
Registration Details
Taiwan FDA Registration: 6dd0f25781c6de0967193c8256cb8bf4
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Device Details

“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
Risk Class 2
MD

Registration Details

6dd0f25781c6de0967193c8256cb8bf4

Ministry of Health Medical Device Import No. 030467

DHA05603046706

Product Details

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.

C Immunology and microbiology devices

C5660 Multiple autologous antibody immunoassay system

Imported from abroad

Dates and Status

Dec 07, 2017

Dec 07, 2027