Taiwan FDA registration d09163795ae6204dac14beb22c51b47d

Imno Consest fluorescent autologous anti-deoxynucleic acid antibody assay system

TW: 伊姆諾康塞斯特螢光自體抗去氧核酸抗體測定系統

Taiwan·Risk Class 2·IMMUNO CONCEPTS NA LTD·Registered Mar 21, 2006 – Mar 21, 2016Cancelled

Registration details

Analysis ID: d09163795ae6204dac14beb22c51b47d
Customs Code: DHA00601619103

Company information

Manufacturer: IMMUNO CONCEPTS NA LTD
Manufacturer Country: United States
Authorized Representative: GRANT TECHNOLOGY CO., LTD.

Product details

Intended Use: Semi-quantitative determination of autologous anti-nDNA antibodies in human serum using an indirect fluorescent antibody assay. It is mainly used to diagnose systemic lupus erythematosus.
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: Mar 21, 2006
Expiry Date: Mar 21, 2016
Cancellation Date: May 10, 2018

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for Imno Consest fluorescent autologous anti-deoxynucleic acid antibody assay system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d09163795ae6204dac14beb22c51b47d and manufactured by IMMUNO CONCEPTS NA LTD. The authorized representative in Taiwan is GRANT TECHNOLOGY CO., LTD..

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