Buy Accurex H12 Hemoglobin Test Strips Online – for better result & accuracy. These Hemoglobin strips are used with URIT Hemoglobin Meter, for the quantitative measurement of total hemoglobin in capillary and venous whole blood. These hb strips are to be used by health care professionals only, not to be used for patient self-testing. Accurex HB Test Strips come with a pack size of 50 strips. The Accrues test strip utilizes Dry Chemistry Colorimeter Method (Azido methemoglobin Method). Meter’s optical detectors automatically measure the change in the membrane Buy Accurex H12 Hemoglobin Test Strips Online – for better result & accuracy. These Hemoglobin strips are used with URIT Hemoglobin Meter, for the quantitative measurement of total hemoglobin in capillary and venous whole blood. These hb strips are to be used by health care professionals only, not to be used for patient self-testing. Accurex HB Test Strips come with a pack size of 50 strips. The Accrues test strip utilizes Dry Chemistry Colorimeter Method (Azido methemoglobin Method). Meter’s optical detectors automatically measure the change in the membrane Operation Principle: The test strip utilizes Dry Chemistry Colorimeter Method (Azido methaemoglobin Method). When a drop of whole blood is applied to the test spot on the strip, blood immediately disperses within the membrane, contacting the reagent. The meter’s optical detectors avtomatically measure the change in membrane reflectance. The intensity of reflectance is inversely proportional to the hemoglobin concentration. Blood Sample Collection: Fresh or EDTA-anticoagulated capillary or venous whole blood may be used. If an EDTA – treated sample is refrigeratted to come to the room temperature before testing. EDTA treated blood samples should be mixed using end to and inversions at least 8 times prior to use, and should be tested within 24nours Do not use the haemolytic sample anticogulants other than EDTA are not recommended for use. Caution: 1. Same as all diagnostic tests, hemoglobin test results should be evaluated with the specific patient’s condition. Any results demonstrating the inconsistency with the patient’s clinical status should be repeated or supplemented with additional test data. 2. Do not touch the test membrane by hand 3. H12 Hemoglobin Test Strips are one-off product, do not use again Storage & Preparation: 1.H12 Hemoglobin Test Strips should be stored at O C-30 C dry and dark places, 2 C – B C is the best storage environment emperatures recommended. Keep away from direct sunlight and heat, must not be frozen, If the container was stored in refrigerated before first use, please don’t take it back into the refrigerator again after first use. 2. H12 Hemoglobin Test Strips are ready to use. No additional preparation is required 3. Enclosed desiccants with lest strip. Remove only those strips needed for testing. The remaining lest strips should be resealed in their onginal container and used up in 3 months after first use. Do not use lest strips and throw away alter expiry date. 4. Use the strip immediately once taking it out af the container, otherwise the result will be incorrect 5. Do not fold or cut the test strip. 6. Used lest strips cannot be used again, dispose them as normal medical waste Direction for Use Operating Instructions: 1. URIT Hemoglobin Meter, H12 Hemoglobin Test Strip, Lancing Device, and disposable blood taking needle. 2. Test steps: 1) Turn the meter on and input the Code Card. Check the Code Card displaying on the meter to ensure it to match the Code Card printed on the lest strip container. Otherwise, the result is incorrect. 2) Massage the patient’s finger from the knuckle up to the tip to stimulate blood flow. Clean the sample area with alcohol and wipe it dry with a sterile gauze pad. 3) Insert the lest strip into the strip holder with the notched end in first and the hole facing up. 4) Puncture the skin on the lower side of fingertip with blood collection needle, and remove 13-15 TIL of whole biood with capillary or other micro blood collection apparatus. While waiting for the instrument to display the blood drop symbol, quickly add the drops to the test hole on the reagent sheet. Please make sure that the blood drop volume can completely cover the test hole but not overflow the test hole. 5) The meter starts the test automatically after the blood sample disperses Once the lest is in process do nol disturb or move the meter or test strip, or press any key. The test result will display within 12 seconds. Qualtiy Control Procedure: Use only H12 Hemoglobin Test Strip with QC substance to perform QC. The range of QC substance is the numerical range indicated on the label of the QCsubstance or test strips. When to do a QCtest: 1. Whenever you suspect that the meter or test strips are not working properly. 2. If your hemoglobin test results are not consistent with how you feel. Other Info Limitations of test Method: H12 Hemoglobin Test Strip is only suitable for testing fresh or whole capillary blood or whole venous blood containing EDTA anticoagulants. Do not use serum, plasma or arterial blood

Buy AccuTest Vitamin D Rapid Card Test (10 Tests) Online from Accurex. The Vitamin D test kit consists of 25 AccuTest Vitamin D individually packed test, devices in foil pouches, 25 pipettes for collecting 10 ul of whole blood, 25 lancets, 1 Buffer Vial (Buffer 5 mL) with stabilizers and, thimerosal, 1 Package Insert. Vitamin D Fast test kit is a rapid chromatographic immunoassay for the semi quantitative detection of Vitamin D levels in human blood/serum. This Vitamin D test provides a preliminary screening test result. INTENDED USE AccuTest Vitamin D is a rapid chromatographic immunoassay for the semi quantitative detection of Vitamin D levels in human blood/serum. This assay provides only a preliminary screening test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. The performance characteristics of this assay have not been established in a pediatric population. PRINCIPLE AccuTest Vitamin D is based on the principle of a competitive enzyme immunoassay. The assay is based on the competition for 25-OH Vitamin D present in blood/serum sample and Vitamin D present on the test line for fixed number of antibody-gold conjugate. Depending upon the concentration of Vitamin D in blood/serum, there will be free antibody-gold conjugate molecules that will bind to Vitamin D on the test strip and will show a colored line in the test line zone. A control line is present in the test window to work as procedural control. PRECAUTIONS 1. For in vitro diagnostic use only. 2. The test is designed for use with human blood/serum only. 3. Reagents must be at room temperature (8⁰C – 30 ⁰C). 4. Do not use if test device packaging is open or damaged. 5. Do not use the product beyond expiration date. 6. Handle all specimens as potentially infectious. Proper handling and disposal methods should be used according to good laboratory practices. 7. Read test results for 10 minutes as required. Results may deteriorate and may not be consistent after 10 minutes. 8. In order to avoid variable results, mix the blood sample thoroughly. 9. A serum sample subjected to repeated freeze thaw cycles may give variable results Direction for Use PROCEDURE 1. Remove the cassette from the sealed pouch and place it on a hard flat surface with the view window facing up (use the cassette as soon as possible). 2. Using a micropipette, add 10 µl of whole blood or 5ul of serum sample directly into the rectangular specimen well (marked with Red drop) of the cassette. 3. Add 3 full drops of Buffer into the square buffer well of the cassette (Do not move the cassette after addition of buffer). 4. Let the cassette sit for 10 minutes and read your results immediately. Results may deteriorate after the 10 minute mark. Other Info STORAGE AND STABILITY The test device should be stored at 8 ⁰C – 30 ⁰C and will be stable until the expiration date stated on the package. The product is humidity sensitive and should be used immediately after being open. INTERPRETATION OF RESULTS Match the color of the test line with the chart provided.

Buy AccuTest HIV – 1/2 Ab Rapid Card Test (50 Tests) Online from Accurex. This Rapid HIV test is a visual, solid phase immunochromatographic assay for qualitative in-vitro diagnostic detection of antibodies against HIV-1 and HIV-2 in human serum/plasma. This HIV test may be used as an aid in diagnosis of HIV infection. In the HIV blood test – A reactive result should be confirmed by supplemental testing as part of a validated HIV testing algorithm. INTENDED USE: AccuTest HIV – 1/2 Ab test is a visual, solid phase immunochromatographic assay for qualitative in-vitro diagnostic detection of antibodies against HIV-1 and HIV-2 in human serum/plasma. The product may be used as an aid in diagnosis of HIV infection. A reactive result should be confirmed by supplemental testing as part of a validated HIV testing algorithm. INTRODUCTION: The Human Immunodeficiency Virus (HIV) is a retrovirus that infects cells of the immune system, destroying or impairing their function. The most advanced stage of HIV infection is Acquired Immunodeficiency Syndrome (AIDS). The general method of detecting infection with HIV is to observe the presence of antibodies to the virus by an EIA method followed by confirmation with any confirmation method. AccuTest HIV – 1/2 Ab is a simple, visual qualitative test that detects antibodies in human serum/plasma. The test is based on immunochromatography and can give a result within 15 minutes. PRINCIPLE: AccuTest HIV – 1/2 Ab employs chromatographic lateral flow device in a cassette format. Colloidal gold conjugated recombinant antigens (Au-Ag) corresponding to HIV-1 (gp120 + gp41) and HIV-2 (gp-36) are dry-immobilized at the end of nitrocellulose membrane strip. HIV-1 & HIV-2 antigens are bound at the Test Zone (1 & 2) respectively. Goat Anti-Mouse IgG antibodies are bound at the Control Zone(C). When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If there are HIV-1 or HIV-2 antibodies in sample, they will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone (1 or 2) where they are captured by the HIV-1 or HIV-2 antigens generating a visible purple line. If the specimen contains antibodies to HIV-1, the specimen will bind to the 1 test line and produce line. If specimen contains antibodies to HIV2, the specimen will bind to the 2 test line. If there are no HIV-1 or HIV-2 antibodies in sample, no purple line is formed in the Test Zone. The gold conjugate will continue to migrate alone until it is captured in the Control Zone (C) by the Goat Anti Mouse IgG antibodies aggregating in a purple line, which indicates that the migration of liquid has been successful. The control line must be present for the test to be valid. PRECAUTIONS: 1. For best results, adhere to instructions provided. 2. All specimens should be handled as potentially infectious. 3. The test device is sensitive to humidity as well as heat. 4. Do not use beyond expiration date. 5. Do not use test kit if pouch is damaged or seal is broken. 6. Use test device immediately after removing from the pouch. 7. The components (test device and assay diluents) in this kit have been quality control tested as a standard batch unit. Do not mix components from different lot numbers. 8. The AccuTest HIV – 1/2 Ab Test devices should be stored at 4 to 30 °C. Do not expose the kit to temperature over 30 °C. 9. Specimen with extremely high concentrations of red blood cells, fibrin should be recentrifuged before use. 10. AccuTest HIV – 1/2 Ab Test Device (Serum/Plasma) is for in vitro diagnostic use only. 11. AccuTest HIV – 1/2 Ab Test Device (Serum/Plasma) will only indicate the presence of antibodies to HIV-1/2 in the specimen and should not be used as the sole criteria for the diagnosis of HIV-1, HIV-2, and/or HIV-1 subtype O infection. 12. For confirmation of reactive test results, specimens should undergo further testing using different assays, such as rapid diagnostic tests, EIA and/or Western blotting in accordance with a validated HIV testing algorithm. 13. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician. 14. Results should not be used to determine the serotype of HIV infections TEST PROCEDURE: 1. Allow the test device, buffer and specimen to reach room temperature (15-30 °C) prior to testing. 2. Remove the test device from the foil pouch and use the test device as soon as possible (within one hour). 3. Place the device on a flat, dry surface. Label with specimen ID. 4. Holding the sample dropper vertically above the test disk, slowly transfer 1 drop (10µl) of sample in to the sample well, then add 2 drops of assay diluent (about 75 µl) and start the timer. 5. As the test begins to work, you will see purple color moving across the result Window in the center of the Test Disk. 6. Wait for the colored lines to appear. Interpret test results at 15 to 20 minutes. Do not interpret test result after 20 minutes. STORAGE AND STABILITY Store as packaged in the sealed pouch at 4-30 °C (storage in refrigerator is permitted). Do not store in the freezer. Protect the test kit from humidly. The test device is stable until the expiration date printed on the test kit and/or sealed test device pouch. Do not use beyond the expiration date. The test device must remain in the sealed pouch until use.

Buy Dengue NS1 Antigen test (Pack of 10 test) from Accurex. This NS1 Antigen Rapid test contains: A Test device in aluminum pouch with a desiccant, Disposable dropper & Pack Insert. Dengue NS1 antigen test utilizes the human serum / plasma followed by solid-phase immuno-chromatographic technology for the qualitative detection of dengue virus NS1 antigen. The membrane strip of the kit contains pre coated anti-dengue NS1 monoclonal antibody on the test band region (T), & goat anti-mouse IgG is pre-coated on the control band region (C). EXPLANATION OF THE TEST Dengue NS1 antigen test utilizes the human serum / plasma followed by solid-phase immuno-chromatographic technology for the qualitative detection of dengue virus NS1 antigen. The membrane strip of the kit contains pre-coated anti-dengue NS1 monoclonal antibody on the test band region (T), and goat anti-mouse IgG is pre-coated on the control band region (C). During testing, if the sample containing dengue NS1 Ag, the complex of the antibody-dengueNS1 Ag-gold conjugate moves laterally on the membrane by capillary action. In this case, the colored band will appear on the membrane in test line (T). Control line (C) should always appear if the test procedure is performed properly PRECAUTIONS 1. For in-vitro diagnostic use only. Do not re-use the test device. 2. The instruction must be followed exactly to get accurate results. 3. Anyone performing an assay with this product must be trained in its use and must be experienced in laboratory procedures. 4. Do not eat or smoke while handling specimens. 5. Wear protective gloves while handling specimens. Wash hands thoroughly afterwards. 6. Avoid splashing or aerosol formation. 7. Clean up spills thoroughly using an appropriate disinfectant. 8. Decontaminate and dispose of all specimens, reaction waste, in a biohazard container. 9. Do not mix and interchange different specimen. 10. The presence of humidity may decrease the stability of the tests. Thus, carry out the test immediately after removing the device from the foil pouch. 11. Do not use it beyond the expiration date. SPECIMEN COLLECTION AND STORAGE Direction for Use 1. Place all specimens, test device and solution. Allow them to room temperature prior to testing (15~30 min.) 2. Please perform the test immediately after removing the device from the foil pouch. 3. With a disposable dropper, load 2-3 drops (50 to 75µl) of specimen into the sample well (S) in the test device. 4. Interpret the test results between 15~20 minutes. Do not read the results after 20 minutes. Other Info STORAGE & EXPIRATION 1) Dengue NS1 Antigen test should be stored between 4~30 ºC 2) Expiration date of this kit is 24 months after its manufacture date. LIMITATIONS OF THE TEST Dengue NS1 antigen test is designed for primary screening test of dengue virus NS1 antigen. Although this can provide fast and easy way to get a result, the testing do not completely exclude the possibility of false positive or negative result caused by various factor. So, refer to the result of the kit, please make a final decision with clinical manifestation, other test results and doctor’s view collectively.

Xpress Gluco strips make the testing experience better. These Glucometer strips are designed for self-testing, for both professional and home use. Accurex Blood Glucose test strips provide accurate results in just 5 seconds. Buy Xpress Gluco Test Strips (Pack of 10 Strips) Online from Accurex Point of Care (POC) Diagnostics. The Sugar machine strips do not require any coding & are compatible with Accurex glucometers only. Sample size: 0.5uL, System Measurement Range: 20-800 mg/dL, Hemocrit Range: 25-55 %, Works only with Accurex Glucometer. TEST PRINCIPLE: ELECTROANALYTICALAMPEROMETRY When blood is added to the Xpress Gluco test strip, the chemicals within the strip react with the blood to create a tiny electrical current. Your meter will read that current and display you the blood glucose level. • Accurex test strips make the testing experience better. • Longer shelf life and clearly marked expiry date. • Designed for self testing for both professional and home use. • Accurate results in just 5 seconds. • Works only with Accurex Glucometer. • Uses only 0.5uL blood sample size • Alternate site testing possible • No-coding required • Compatible with Accurex glucometers only CHEMICAL COMPOSITION: Each Xpress Gluco test strip contains: • Enzyme Glucose Oxidase (Aspergillus Sp.) ≥ 1IU • Other ingredients (Mediator, Surfactant, Stabilizing agents etc.) ≥ 200μg • Xpress Gluco Test Strips are used to measure glucose in Capillary whole blood outside of the body (in vitro diagnostic use). • Use Xpress Gluco Test Strips only with the Xpress Gluco Blood Glucose Test System. • Xpress Gluco Test Strips are plasma calibrated to allow easy comparison of results with laboratory methods. • This system is not intended for use in the diagnosis of diabetes mellitus. • This system is not recommended for Neonates Blood samples. Result interpretation: • Xpress Gluco Meter delivers plasma equivalent results and are displayed in mg/dL. • The measurement range of the meter is 20-800mg/dL. • Your blood glucose values will vary due to such things as diet, time of day and what you are doing. Your healthcare professional will help you to understand these variations. You should set your own range of expected blood glucose values, testing times, and discuss your blood glucose results with your healthcare professional. • When blood is added to the Xpress Gluco test strip, the chemicals within the strip react with the blood to create a tiny electrical current. • Your meter will read that current and display you the blood glucose level. • Use fresh whole blood sample only. • Sample size: 0.5uL • Analysis time: 5 seconds • System Measurement Range: 20-800 mg/dL • Hemocrit Range: 25-55 % Safety Information Important saftey handling: • Wash hands thoroughly, with soap and water before and after testing • Never use fingerstick devices for more than one person. Use auto disabling, single use fingerstick devices for assisted monitoring of blood glucose. Storage & Handling: • Store the strips in their original vial in a cool, dry place between: 0°-50° C (32° and 122° F). Keep away from direct sunlight and heat. • Do not refrigerate or freeze. • When you take a strip from the vial, close the cap immediately. Use the strip immediately. • Check the expiry date on the vial. If the expiry date has passed, do not use the strips. Important health-related information: • Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult your physician or doctor immediately. • Test results below 70 mg/dL. mean low blood glucose (hypoglycemia). • Test results greater than 180 mg/dL mean high blood glucose (hyperglycemia). • If you get results below 70 mg/dL or above 180 mg/dL and do not have symptoms of hypoglycemia or hyperglycemia, repeat the test. If you have symptoms or continue to get results that fall below 70 mg/dL or above 180 mg/dL, follow the treatment/advice of your healthcare professional. • If you are experiencing symptoms that are not consistent with your blood glucose test and you have followed all instructions described in the Xpress Gluco owner’s booklet, consult your healthcare professional Other Info UNEXPECTED RESULTS: Very high or very low blood glucose readings can indicate a serious medical condition. Repeat the test if you see an unusual reading. If these results are still unusual, or do not match your symptoms, contact your health care professional for advice. Hi or Low readings may indicate hyper or hypoglycemia and should be treated immediately. ABOUT ALTERNATIVE SITE TESTING: Test can be done on alternative site (other than fingertip). However, there are limitations. Please consult your physician before perfoming AST.

Product Description: It’s a modern and advanced analyzer in Hemostasis. This single channel coagulation analyzer redefines the benefits in its class Erba. ECL 105 can perform PT, APTT, Fibrinogen, Thrombin Time, All Factiors, Lupus and DDimer. Product Features: Clotting Tests such as PT, aPTT, Fibrinogen, Thrombin time, Factors, Lupus anticoagulant performed using Light scatter principle Tests like D Dimer performed using Immuno-turbidimetry principle Interactive touch screen interface Clotting Graph provides details of the clotting testCuvette and reagent management software Twelve levels of QC with Levy-Jennings Plot- Identifies random and systematic errors Temperature stability at 37 degree C to perform the tests. Low Reagent Consumption USB Connectivity CE mark Product Applications: ECL 105 has uses in various routine IVD labs for doing routine PT and aPTT It has application in Blood Banks for Quality Control of Fibrinogen and Factor VIII It is used as Standby to bigger systems, in accredited centres It is used in Research Facilities to perform PT and aPTT on animal samples such as rat, mouse, rabbit, hamsters etc Key Specifications: Single channel semi-automated hemostasis system It can analyze 1 test at a time Sample id can be 14 digits alphanumeric, with progressive id or custom id options It is also possible to have a second position of assay preparation/incubation during the analysis of the current one, using preparation line option Optically detects and automatically moves to the next assay steps and auto starts the measurements Tests principles: Clotting (scattered light at 640nm) Immuno-turbidimetric (turbidimetry at 800nm) Dimensions / Weight: Dimension : 216 x 205 x 75 mm Weight : ~1 kg Environmental requirements: Operating Temperature : 17-32°C Humidity: Max. 80% Relative Humidity, non-condensing Power: Power Supply : 100-240 VAC and 50/60 Hz Power Consumption : 45 Watts In-Rush Power : 150 VA or less Calibrations: Up to 6 calibration levels per assay Storage of the active calibration curve Quality Controls: Up to 12 different control total can be assigned to any given assay Automatic Levey-Jennings plotting Automatic statistics calculation Storage of Quality Control results Stored Results: Independent storage allocation in the instrument memory for Quality Control (QC) and patient determinations Up to 1000 results for QC determinations Up to 1000 results for patients New results automatically replace the oldest results of the appropriate category past the maximum storage allowance Reaction curves are exclusively stored on the external USB pen drive. Regular backup and file purging is recommended from the USB pen drive to insure rapid operations. USB pen drive, FAT32 formatted

Product Description: It’s an advanced analyzer for Complete Hemostasis. This four channel coagulation analyzer redefines the benefits in its class. Erba ECL 412, can perform PT, APTT, Fibrinogen, Thrombin Time , All Factors, Lupus , Protein S, Protein C , Antithrombin III and DDimer. Product Features: Clotting Tests such as PT, aPTT, Fibrinogen, Thrombin time, Factors, Lupus anticoagulant, Protein S performed using Light scatter principle. Protein C, Antithrombin III done by Chromogenic Principle Tests like D Dimer performed using Immuno-turbidimetry principle Interactive touch screen interface Clotting Graph provides details of the clotting test Cuvette and reagent management software Twelve levels of QC with Levy-Jennings Plot- Identifies random and systematic errors Temperature stability at 37 degree C to perform the tests Low Reagent Consumption USB Connectivity CE mark Product Applications: ECL 412 has uses in various routine IVD labs for doing routine PT and aPTT It has application in Blood Banks for Quality Control of Fibrinogen and Factor VIII It is used as Standby to bigger systems, in accredited centers It is used in Research Facilities to perform PT and aPTT on animal samples such as rat, mouse, rabbit, hamsters etc General Specifications: 4 channel semi-automated hemostasis instrument It can perform 4 simultaneous tests of the same parameter Sample id can be 14 digits alphanumeric, with progressive id or custom id options It is also possible to have a second row of assay preparation/incubation during the analysis of the current line, using preparation line option It can run assays in single or duplicate (programmable per assay) Optically detects and automatically moves to the next assay steps and auto starts the measurements Tests principles: Clotting (scattered light at 640nm) Chromogenic (colorimetry at 405nm) Immuno-turbidimetric (turbidimetry at 800nm) Dimensions / Weight: Dimension : 300 x 290 x 90 mm Weight : 3 kgs Environmental requirements: Operating Temperature : 17-32°C Humidity: Max. 80% Relative Humidity, non-condensing Power: Power Supply: 100-240 VAC and 50/60 Hz Power Consumption: 45 Watts In-Rush Power: 150VA or less Calibrations: Up to 6 calibration levels per assay Storage of the active calibration curve Quality Controls: Up to 12 different control names total can be assigned to any given assay Automatic Levey-Jennings plotting Automatic statistics calculation Storage of Quality Control results Stored results: Independent storage allocation in the instrument memory for Quality Control (QC) and patient determinations Up to 600 results for QC determinations (run in duplicate) Up to 900 results for patients (run in duplicate) New results automatically replace the oldest results of the appropriate category past the maximum storage allowance Reaction curves are exclusively stored on the external USB pendrive. Regular backup and file purging is recommended from the USB pendrive to insure rapid operations. (We recommend at least a monthly purge from a computer to back up and remove CH files) USB pendrive , FAT32 formatted

Product Features: Better precision, CV < 2.5 % Patented CLE technology enables complete elimination of labile glycohemoglobin ensuring accurate HbA1c results. HbA1c test results in 3.5 minutes with HbA2/HbF flagging. Separation of hemoglobin fractions Complete removal of labile fraction up to 10% No interference of HbF up to 10% No interference of lipemia or icterus, can run on non-fasting patient samples HbA1c reportability presence of HbS, HbC, HbD and HbE Compact bench top model User friendly touch screen operation Sampling from multiple sized primary tubes, including microcapillary collection tubes On board QC functions with Levey-Jennings and statistical calculations Unlimited storage of calibration, QC data and chromatograms No sample preparation required Simple reagent and column replacement Automated maintenance RFID reagent identification and tracking Automatic barcode identification of samples NGSP certified Calibrators and Controls IFCC traceable Complete kit with buffers, calibrator and column Product Application: Hba1c Testing Sampler Handler: 10 Position Rack Loader, positive identification by internal barcode reader Sample Type: Whole blood on EDTA K3 or K2 anticoagulant Haemolysate from EDTA whole blood samples Time for Analysis: Throughput approximately 3.5 minutes between samples Interferences: Complete removal (not separation) of labile up to 10% Sampling System: Sample Aspiration Probe coupled with a high precision, Sample Aspiration Volume: 14.5 µl in whole blood, 670 µl in lysate mode. Pump: 2 high pressure syringe pumps Detector Type: UV-Vis Reagent Traceability: RFID Printer: Built- in thermal printer with possibility to connect to external printer

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.