CLIAlyzer is an intuitive bench-top chemiluminescent analyzer allowing for quick operation and use. CLIAlyzer delivers results when paired with our RapidLight tests. Laboratories can run multiple specimen options and six tests simultaneously, providing up to 24 test results per hour. The CLIAlyzer is an in vitro diagnostic device used for the quantitative determination of concentrations of various analytes found in serum, whole blood, or plasma specimens. Compact size Automated walkaway system Easy operation with 7-inch touchscreen Barcode reader reduces manual entry errors Results on screen, on a printout, or uploaded to database Storage capacity of 100,000 test results Laboratory Information System (LIS) connectivity High accuracy and precision with highly sensitive PMT for signal detection Assay results as quick as 15 minutes (test-specific) Compatibility with whole blood, serum, plasma (test-specific) Six cartridge positions Automatic detection of test parameter through barcode on test strip, thus reducing any user-related errors Low maintenance analyzer due to no storage of buffer System: Automated chemiluminescence system Interface: 7-inch color touch screen Methodology: Magnetic particle-based assay with chemiluminescence detection Reaction mode: Batch mode Sample type: Serum, plasma, whole blood (test specific) Sample positions: 6 Volume: 420mm x 610mm x 321mm Weight: 35kg Connectivity: USB, RS232, LIS connection Barcode Scanner: 1-D & 2-D barcode

INTENDED USE The Finecare™ Vitamin D Rapid Quantitative Test along with Finecare™ FIA Meter is a fluorescence immunoassay quantitative determination of total 25(OH) D2/D3 level in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency. STORAGE AND STABILITY 1. Store at 4°C～30°C up to the expiration date. 2. The solid marker bottle can be stored at 2°C～8°C for 28 days after being reconstituted. 3. Do not remove the device from the pouch until ready to use. The Test Cartridges should be used within 1 hour once opened.

Cortisol Rapid Quantitative Test The Finecare™ Cortisol Rapid Quantitative Test is a fluorescence immunoassay for quantitative determination of Cortisol in human serum, plasma or whole blood. The test is used as an aid to the screening of adrenal dysfunction and assessment of the treatment effect. 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™ Ferritin Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for quantitative determination of Ferritin in human whole blood, serum or plasma. The test is used as an aid to the assessment of iron deficiency anemia. STORAGE AND STABILITY 1. Store the test kit at 4 ~30℃ up to the expiration date printed on the package. 2. Do not remove the Test Cartridge from the pouch until ready to use. The Test Cartridge should be used within 1 hour once opened.

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.

Dengue NS1 Antigen Test The Finecare™ Dengue NS1 Ag Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for qualitative detection of Dengue NS1 antigen in whole blood, serum or plasma specimen. It is useful as an aid in screening of early Dengue virus infection.

Total IgE Rapid Quantitative Test The Finecare™ Total IgE Rapid Quantitative Test along with Finecare™ FIA Meters is a fluorescence immunoassay for quantitative measurement of Total IgE in human whole blood, serum and plasma. The test is used as an aid in diagnosis of allergic disease.

Finecare™ H.pylori Ag Rapid Quantitative Test The Finecare™ H.pylori Ag Test along with Finecare™ FIA Meters is a fluorescence immunoassay used for qualitative determination of H. pylori Ag in human feces. The test is used as an aid in the diagnosis of H. pylori infection. For in vitro diagnostic use only. For professional use only.

Vitamin B12 Rapid Quantitative Test The Finecare™ Vitamin B12 Rapid Quantitative Test along with Finecare™ FIA Meters is a fluorescence immunoassay quantitative determination of vitamin B12 level in human serum or plasma. The test is used as an aid in the diagnosis of Vitamin B12 deficiency.