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'2 viruses'

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immunoassayReagents

INTENDED USE The Finecare™ 2019-nCoV RBD Antibody Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for qualitative and semi-quantitative detection of spike receptor-binding domain (RBD) antibodies of novel coronaviruses (2019-nCoV) in human fingerstick whole blood, venipuncture whole blood, serum or plasma specimen. The 2019-nCoV RBD antibodies are protective antibody produced by the human body after inoculation with 2019-nCoV vaccine or infection with 2019-nCoV. The test is intended as an aid to assess the adaptive humoral immune response to the 2019-nCoV RBD protein. STORAGE AND STABILITY 1. Store at 4~30°C in the sealed pouch up to the expiration date printed on the package. Do not freeze. 2. The test device should be used within 1 hour after taking out from the foil envelope. 3. Keep away from sunlight, moisture and heat. 4. Kit contents are stable until the expiration date printed on the outer box.

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Immunoassay Reagents

INTENDED USE The Finecare™ 2019-nCoV lgM/lgG Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for qualitative detection of IgG and IgM antibodies of novel coronaviruses (2019-nCoV) in human whole blood, serum and plasma specimen. Clinically, the test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by 2019-nCoV. The test provides preliminary test results. Negative results cannot exclude the possibility of 2019-nCoV infection and they cannot be used as the sole basis for treatment or other management decision. STORAGE AND STABILITY 1. Store at 4-30°C in the sealed pouch up to the expiration date printed on the package. Do not freeze. 2. The test device should be used within 1 hour after taking out from the foil envelope. 3. Keep away from sunlight, moisture and heat. 4. Kit contents are stable until the expiration date printed on the outer box.

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Prescription drugs

SARS CoV2 Corona IgG ELISA Test Corona IgG ELISA is intended to be used for the qualitative detection of IgG antibodies to Novel Corona viruses in human serum or plasma. It is an IgG Elisa-based test that is done to detect the Immunoglobulin G (IgG) antibody. The IgG antibodies are produced between 10-14 days of the pathogen’s appareance. If the IgG antibody is detected, it can be concluded that the person was exposed to SARS-CoV2. IgG ELISA is indended as an aid in identifying indviduals Specificity: 96% Sensitivity: 93% Pack Size: 96 Tests

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immunoassayReagents

INTENDED USE The Finecare™ Estradiol (E2) Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA Meters is for quantitative measurement of Estradiol (E2) in human whole blood, serum or plasma. The test is used as an aid to the evaluation of ovarian diseases. STORAGE AND STABILITY 1. Store the test kit at 4~30℃ up to the expiration date. 2. If removed from refrigerator, allow the test for 30 minutes to return to room temperature before testing. 3. Do not remove the cassette from the pouch until ready to use. The Test cassette should be used within 1 hour once opened.

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immunoassayReagents

INTENDED USE The Finecare™ β2-MG Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of β2-MG (Beta-2-Microglobulin) concentration in human plasma, serum or whole blood. The test is used as an aid for the diagnosis of renal disease. STORAGE AND STABILITY 1. Store the test kit at 4℃~30℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing. 3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.

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immunoassayReagents

INTENDED USE The Finecare™ Lp-PLA2 Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of Lp-PLA2 in human serum, plasma or whole blood. The test is used as an aid to the assessment of the coronary heart disease (CHD) and ischemic stroke. STORAGE AND STABILITY 1. Store the test kit at 4℃-30℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing. 3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.

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