Abelle's anti-cyclic citrullinated peptide antibody test reagent set - Taiwan Registration d5f019ac005ec1f5d52b4398adfaa45d
Access comprehensive regulatory information for Abelle's anti-cyclic citrullinated peptide antibody test reagent set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d5f019ac005ec1f5d52b4398adfaa45d and manufactured by Axis-Shield Diagnostics Limited;; ABBOTT GMBH. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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Device Details
Registration Details
d5f019ac005ec1f5d52b4398adfaa45d
DHA05603212501
Product Details
The performance change (adjusted textual description) is as follows: This product is used for the semi-quantitative detection of IgG-type autologous antibodies specific for cyclic citrullinated peptide (CCP) in human serum or plasma by chemical cold light microparticle immunoassay (CMIA) on the Alinity i analyzer.
A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
C.5775 Hydrogenic factor immunoassay system;; A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products
Contract manufacturing;; input
Dates and Status
Jan 14, 2019
Jan 14, 2029

