Taiwan FDA registration c01140e867d0fb8aeca21c58cbe1b715

Ilia Ro52 antibody detection reagent

TW: 宜立亞Ro52抗體檢測試劑

Taiwan·Risk Class 2·PHADIA AB;; PHADIA GMBH·Registered May 24, 2013 – May 24, 2028Active

Registration details

Analysis ID: c01140e867d0fb8aeca21c58cbe1b715
Customs Code: DHA00602470007

Company information

Manufacturer: PHADIA AB;; PHADIA GMBH
Manufacturer Country: Sweden;;Germany
Authorized Representative: PHADIA TAIWAN INC.

Product details

Intended Use: This product is used in Fadia 100, Fadia 200 and Fadia 250 instruments for the quantitative determination of IgG antibodies of Ro52 in human serum and plasma in vitro. A tool to assist in the clinical diagnosis of Schogren's syndrome and systemic lupus erythematosus (SLE).
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: May 24, 2013
Expiry Date: May 24, 2028

About this record

Access comprehensive regulatory information for Ilia Ro52 antibody detection reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c01140e867d0fb8aeca21c58cbe1b715 and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..

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