High Accuracy CA19-9 Elisa Test Kit

INTENDED USE

Immunoassay for the in vitro quantitative determination of CA19-9 antigen in human serum.

Materials provided

• Coated Microplate, 8 x 12 strips, 96 wells, pre-coated with monoclonal CA19-9.

• Calibrators, 6 vials, 0.5 ml each, ready to use; Concentrations: 0(A), 10(B), 40(C), 100(D), 200(E)and 400(F) U/ml

• Conjugate, 1 vial, 12mL of HRP (horseradish peroxidase) labeled mouse monoclonal anti-CA19-9.

• Substrate Solution A, 1 vial, 6ml, ready to use, H 2 O 2 in acete buffer.

• Substrate Solution B, 1 vial, 6ml, ready to use, TMB solution.

• Stop Solution, 1 vial, 6 ml of 1 mol/l sulfuric acid.

• WashSolution Concentrate, 1 vial, 50ml (20X concentrated), PBS-Tween wash solution.

• IFU, 1 copy.

• Plate Lid: 2 piece.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world