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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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d5f019ac005ec1f5d52b4398adfaa45d
Registration Details
Taiwan FDA Registration: d5f019ac005ec1f5d52b4398adfaa45d
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Device Details

Abelle's anti-cyclic citrullinated peptide antibody test reagent set
TW: ไบžๅŸนๆŠ—็’ฐ็“œๆฐจ้…ธ่‚ฝๆŠ—้ซ”ๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

d5f019ac005ec1f5d52b4398adfaa45d

DHA05603212501

Company Information

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