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'1 test'

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immunoassayReagents

INTENDED USE The Finecare™ S100β Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for quantitative determination of S100β in human serum, plasma or whole blood. The test is used as an aid to the assessment of the level of cerebral injury. 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™ HbA1c Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of Hemoglobin A1c in human blood. The test is used as an aid to monitor long-term glycemic status in patients with diabetes mellitus. 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™ 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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Rapid Test

Intended Use Dengue Day 1 Test is a rapid solid phase immuno-chromatographic test for the qualitative detection of Dengue NS1 Antigen and differential detection of IgM and IgG antibodies to Dengue virus in Human serum/plasma. This test is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of Dengue infection & presumptive diagnosis between primary and secondary Dengue infection. Salient Features First line testing kit for detecting dengue infection from day 1 using NS1 Antigen & differential detection of IgM & IgG Antibodies. Diagnosis of both Primary & Secondary Infection. Detection of all the 4 Dengue serotypes (DEN-1, DEN-2, DEN-3 and DEN-4). Highly Sensitive & Highly Specific Long shelf life: 30 months at 2-30°C. Convenient pack sizes: 10 Tests, 30 Tests & 50 Tests.

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Rapid Test

Intended Use Dengue NS1 Antigen self-test is a rapid solid phase immune-chromatographic test for the qualitative detection of Dengue NS1 Ag in human whole blood/serum/plasma. This test is intended to be for home use with self-collected whole blood specimens from individuals aged 18 years or above( or collected by adults for individuals below 18 years of age) as well as for professional use with venous Whole blood/Serum/Plasma samples. This test is for in-vitro diagnostic use only & is designed as an aid in the early diagnosis of dengue infection patients with clinical symptoms. Salient Features Rapid, Visual, Home test for qualitative detection of Dengue NS1 antigen detection in human whole blood/serum/plasma. Finger prick sample can be used. Single test pack. All material to perform the test & its disposal are provided with the kit. Based on Sandwich principle.\ Detection of Dengue in Seronegative stage i.e. from Day 1 of fever. Detection of all 4 serotypes of dengue virus. Reliable diagnosis of both primary and secondary infection. 100% Sensitivity & 100 % Specificity. Shelf life: 30 month at 2-30 °C.

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