Taiwan FDA registration 35e2d6dae1756c40cbefdaa996c36e09

Zeus Antinuclear Antibody Immunoassay System II

TW: 宙斯抗核抗體免疫檢驗系統 II

Taiwan·Risk Class 2·ZEUS SCIENTIFIC, INC.·Registered Nov 15, 2007 – Nov 15, 2027Active

Registration details

Analysis ID: 35e2d6dae1756c40cbefdaa996c36e09
Customs Code: DHA00601867601

Company information

Manufacturer: ZEUS SCIENTIFIC, INC.
Manufacturer Country: United States
Authorized Representative: TRUGENE DIAGNOSTICS, INC.

Product details

Intended Use: Semi-quantitative detection of immunoglobulin G-level antibodies against 8 different analytes in human serum (including SSA, SSB, Sm, RNP, Scl-70, Jo-1, centriole B, and histain), IgG level antibodies in human blood, and IgG level antibodies at ANA.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.5100 抗核抗體免疫試驗系統
Import Information: import

Dates and status

Registration Date: Nov 15, 2007
Expiry Date: Nov 15, 2027

About this record

Access comprehensive regulatory information for Zeus Antinuclear Antibody Immunoassay System II in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 35e2d6dae1756c40cbefdaa996c36e09 and manufactured by ZEUS SCIENTIFIC, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..

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