INTENDED USE The Finecare™ TSH Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of thyroid stimulating hormone (TSH) in human whole blood, serum or plasma. This test is used as an aid to assist in the assessment of pituitary gland and thyroid function. 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.

INTENDED USE The Finecare™ Progesterone Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of progesterone in human serum, plasma or whole blood. The test is used as an aid to the track ovulation. 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.

INTENDED USE The Finecare™ Testosterone Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for quantitative measurement of Testosterone in human whole blood, serum or plasma. The test is to be used as an aid in the diagnosis of diseases related to abnormal testosterone levels. STORAGE AND STABILITY 1. Store the test kit at 4~30ºC up to the expiration date printed on the package. 2. If removed from refrigerator, allow the test to return to room temperature for 30 minutes 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.

The Finecare™ One Step D-Dimer Rapid Quantitative Test is a screening test with fluorescence immunoassay to be used along with Finecare™ FIA System for quantitative analysis of cross-linked fibrin degradation products containing D-Dimer in human whole blood or plasma. The test is used as an aid in detecting the presence and assessing the degree of intravascular coagulation or thromboembolic events including pulmonary embolism.

INTENDED USE The Finecare™ One Step cTnT Rapid Quantitative Test along with Finecare™ FIA Meters is a fluorescence immunoassay for quantitative determination of cTnT concentration in human venous whole blood, serum or plasma specimen. It is mainly used as an aid to the diagnosis of myocardial infarction. STORAGE AND STABILITY 1.Store at 4~30 °C up to the expiration date printed on the package. 2. Do not remove the Test Cartridges from the pouch until ready to use. The Test Cartridges should be used within 1 hour once opened.

Luteinizing Hormone (LH) URINE RAPID TEST For Qualitative Detection of Luteinizing Hormone (LH) Urine Rapid Test Type : Device Pack Size : 25 T

The OnSite Troponin I Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of cardiac Troponin I (cTnI) in human serum, plasma or whole blood at a level equal to or higher than 1 ng/mL. It can be performed within 15 minutes by minimally skilled personnel, and without the use of laboratory equipment. The OnSite Troponin I Combo Rapid Test is intended to be used by healthcare professionals as an aid in the diagnosis of acute myocardial infarction (AMI). Any use or interpretation of this preliminary test result must also rely on patient’s symptoms and the professional judgment of a physician. A more precise test method such as an instrument method must be used to confirm the test result obtained by this device. Normally the level of cTnI in the blood is very low. cTnI is released into the blood stream in forms of free cTnI and cTnI-C-T complex at 4-6 hours after myocardial cell damage. The elevated level of cTnI could be as high as 50 ng/mL during 60-80 hours after AMI and remains detectable for up to 10-14 days post AMI. Therefore, circulating cTnI is a specific and sensitive marker for AMI. Clinical performance: Relative Sensitivity: 95.8% (95% CI: 91.5-97.9%) compared to a reference CLIA Relative Specificity: 99.7% (95% CI: 98.8-99.9%) Analytical sensitivity: The detection limit of cTnI is 1.0 ng/mL or greater in serum, plasma or whole blood specimen Cross-reactivity: No cross reactivity with 10 µg/mL skeletal muscle TnI, 2,000 ng/mL cardiac muscle TnT, 20 µg/mL cardiac muscle Myosin Dose hook effect: No hook effect was observed for cTnI at concentrations up to 3,521 µg/mL Interference: No interference was seen with 20 mg/dl Acetaminophen, 20 mg/dl Acetylsalicylic acid, 10.5 g/dl Albumin, 20 mg/dl Ascorbic acid, 1,000 mg/dl Bilirubin, 20 mg/dl Caffeine, 800 mg/dl Cholesterol, 200 mg/dl Creatinine, 20 mg/dl Gentistic acid, 1,000 mg/dl Hemoglobin, 600 mg/dl Oxilic acid, 1,600 mg/dl Triglycerides Shelf life: 24 months Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Sample diluent (REF SB-R3002, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Insert MedlinePlus: Troponin Test Poster

The OnSite H. pylori Ab Combo Rapid Test is a sandwich lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG, IgM and IgA) against Helicobacter pylori (H. pylori) in human serum, plasma or whole blood. Uses serum, plasma or whole blood specimen No need to avoid certain medications Non-invasive, easy to perform procedure Time to result is 15 minutes Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Sample diluent (REF SB-R0191, 5 mL) Package insert (instruction for use) CTK Products at a Glance Flyer H. pylori Rapid Tests Training Presentation Inserts Poster U.S. CDC-H. pylori: HP Facts

The OnSite Typhoid IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the detection and differentiation of IgG and IgM anti-Salmonella typhi (S. typhi) and paratyphi in human serum, plasma or whole blood. Utilizes O antigen and H antigen from both typhi and paratyphi serovars to maximize sensitivity Differentiates between IgG and IgM to determine stage of infection One step procedure minimizes operator error due to sample preparation Test result within 15 minutes allows medical professionals to take immediate action High level of reproducibility Test kits can be used and stored in a wide range of temperatures Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Sample Diluent (REF SB-R0161, 5 mL/bottle) Package insert (instruction for use) CTK Products at a Glance Flyer Inserts U.S. CDC Typhoid Homepage: About Typhoid WHO: Health Topic for Typhoid