“EUROIMMUN” EUROLINE ANA-Profile 1(IgG) - Taiwan Registration 84df1076214ba9c6b3b64ed172611b31
Access comprehensive regulatory information for “EUROIMMUN” EUROLINE ANA-Profile 1(IgG) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 84df1076214ba9c6b3b64ed172611b31 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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Device Details
Registration Details
84df1076214ba9c6b3b64ed172611b31
Ministry of Health Medical Device Import No. 031963
DHA05603196300
Product Details
This product is used for qualitative testing of 12 different autoantibodies such as nRNP/Sm, Sm, SS-A (native), Ro-52, SS-B, Sc1-70, Jo-1, CENP B, dsDNA, nucleosomes, histones and ribosomal P-proteins in human serum or plasma.
C Immunology and microbiology devices
C5100 Antinuclear antibody immunoassay system
Imported from abroad
Dates and Status
Dec 12, 2018
Dec 12, 2028