Product Description
Thank you for purchasing Zybio Chemiluminescence Immunoassay Analyzer. Allow us to
express our appreciation.
Please read this operation manual carefully before use.
The pictures in this operation manual are used for illustrations or examples only and are not
intended for other purposes. Please consult the actual product for accurate display.
Please consult this operation manual whenever necessary.
Product name: Chemiluminescence Immunoassay Analyzer.
Specifications and models: EXI1800, EXI1810, EXI1820, EXI1830.
Administration class: Class II.
Production license No.: Chongqing NMPA Production License No. 20150016.
Registration certificate No./Product Technical Requirement No.: Chongqing Instrument
Registration and approval No. 20202220259.
Product composition: This product consists of analysis unit, operation unit and accessories.
The analysis unit is composed of a sample processing system, a reagent processing system,
a cuvette transportation system, a sample reagent injection system, a reaction solution
mixing system, a magnetic separation system, a substrate system, and a photometric and
reaction system; The operation unit includes a display, a hand-held barcode scanner and an
analysis software; The accessories include a wash buffer container, a wash buffer floating
ball sensor, a liquid waste container and a liquid waste floating ball sensor. The software of
this product is a control software.
Intended use: This product adopts a chemiluminescence method based on alkaline
phosphatase-catalyzed reaction, in combination with matching testing reagents, and is
clinically used for the qualitative or quantitative tests of the subjects in human serum,
plasma and urine samples, including subjects related to hormones, diabetes, cardiac
markers, tumor markers, and infectious diseases.
Registrant / manufacturer name: Zybio Inc.
Registrant / manufacturer address: Floor 1 to Floor 5, Building 30, No.6 of Taikang Road,
Block C of Jianqiao Industrial Park, Dadukou District, 400082 Chongqing, PEOPLE’S
REPUBLIC OF CHINA.
Service life: 10 years, as determined by lifetime testing. During use, you shall maintain, care
and repair this product in accordance with the requirements in this manual to ensure the
safety and effectiveness.
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