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“EUROIMMUN” EUROLINE Paraneoplastic Neurologic Syndromes 12 Ag (IgG) - Taiwan Registration 7f6950473583cc60aef1e279284447f4

Access comprehensive regulatory information for “EUROIMMUN” EUROLINE Paraneoplastic Neurologic Syndromes 12 Ag (IgG) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7f6950473583cc60aef1e279284447f4 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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7f6950473583cc60aef1e279284447f4
Registration Details
Taiwan FDA Registration: 7f6950473583cc60aef1e279284447f4
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Device Details

“EUROIMMUN” EUROLINE Paraneoplastic Neurologic Syndromes 12 Ag (IgG)
TW: “歐蒙” 免疫膜條法副腫瘤神經綜合症IgG抗體篩選12抗原試驗系統
Risk Class 2
MD

Registration Details

7f6950473583cc60aef1e279284447f4

Ministry of Health Medical Device Import No. 032382

DHA05603238208

Product Details

This product must be used with EUROLineScan software for in vitro qualitative detection of IgG antibodies against 12 different antigens in human serum or plasma: Amphiphysin, CV2, PNMA2 (Ma2/Ta), Ri, Yo, Hu, recoverin, SOX1, titin, zic4, GAD65, Tr (DNER) to diagnose paraneoplastic neurological syndrome (PNS).

C Immunology and microbiology devices

C5660 Multiple autologous antibody immunoassay system

Imported from abroad

Dates and Status

Mar 26, 2019

Mar 26, 2024