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AnemoCheck Home is intended for home use for the determination of hemoglobin level in whole blood from a finger stick by people over the age of 18. This device is intended for people with anemia caused by iron deficiency anemia, vitamin B12 deficiency anemia, folate deficiency anemia, or who have chronic anemia due to sickle cell disease or thalassemia. AnemoCheck Home tests are for in vitro diagnostic use only. Prescription Use Only.

AnemoCheck Home is a home use with prescription anemia test that is semiquantitative, color based, single use test for hemoglobin level determination. Simply, a user performs a finger stick, less than one drop of blood (5uL) is collected into a collection tube within the test cap, the test cap is mated with the test body and shaken. After 2 minutes of development time, the resulting color of the test solution correlates to a color on a color card. The color results correlate to total hemoglobin levels. As shown, the colors range from blue to red (blue and green indicating low hemoglobin levels, yellow indicating slightly decreased hemoglobin levels and orange and red indicating high levels of hemoglobin), with 1.0 g/dL color block resolution. Users may assign values in between two color blocks for a resolution of 0.5 g/dL. AnemoCheck Home is rapid (2 minutes), simple to use, disposable, and is a stand-alone system that does not require electrical power, additional equipment, or training. The device is semi-quantitative and designed to use a specific test body, test cap, blood collection tube and chemical reagent solution. The blood collection tube serves as a pipette and measuring instrument. No dilution is required or measuring is required by the lay user. AnemoCheck Home leverages the same chemistry and technology used in AnemoCheck (K163215). When blood is mixed with the pre-filled solution, an oxidation-reduction (redox) 3.3.5.5.5 tetramethylbenzidine (TMB) and hydrogen peroxide, leading to stable oxidized TMB products. The products exhibit different colors based on the amount of total hemoglobin present in the sample. After 2 minutes, the resulting color of the solution then allows for visual interpretation with the naked eye using a color card for determination of hemoglobin (g/dL).

The AnemoCheck is an in vitro diagnostic semi-quantitative assay for use in point-of-care, clinical and doctor office laboratories for the determination of hemoglobin level and estimation of hematocrit percentage (within normal hemoglobin range) in anticoagulated (K2EDTA, heparin or citrate) whole blood (capillary or venous). AnemoCheck should not be used to evaluate neonatal samples (birth - 1 month).

The AnemoCheck™ is a semi-quantitative colorimetric assay for determination of total hemoglobin (g/dL) and calculated hematocrit (%) in whole blood. Capillary or venous blood may be used. The assay is rapid (development time is 2 minutes) and is a manual test that does not require electrical power or additional equipment.

The AnemiaPro™ Self-Screener is intended for over-the-counter distribution, for the determination of hemoglobin concentration in a self-collected capillary whole blood sample. The device is not intended for use in neonates.

The device is a kit containing the materials necessary to self-collect and test a capillary blood sample using a single-use, disposable unit. The test unit is a self-contained plastic housing for a nitrocellulose-based test strip, which employs the principals of blood cell separation. The plasma that is obtained during blood separation migrates through the test strip, and the migration front is made visible by staining with an impregnated dye. The plasma migration distance is linearly and inversely proportional to hemoglobin concentration. The kit is comprised of a blood testing unit packaged in a foil pouch, alcohol prep pad, disposable lancets, gauze pad, bandage strip, and collection instructions containing information about anemia.

The Stat-Site® M Hgb System is for in-vitro diagnostic use only. The Stat-Site® M Hgb Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® M Hgb meter.

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The HemoSite® Test System is a device for in vitro diagnostic use only. The GDS® HemoSite® Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® Meter in a point-of-care setting such as a physician's office or hospital.

The HemoSite® Test System is a whole blood hemoglobin measurement device which consists of the Stat-Site® Meter (K911801), HemoSite® Test Card and {lot-specific} HemoSite® Test Module. The test employs dry reagent technology based on the azidemethemoglobin method. The blood sample is applied to one side of the HemoSite® Test Card and the color develops on the opposite side. The color produced is directly proportional to the concentration of hemoglobin in the sample and is read using light reflectance at a specific wavelength; the reflectance reading is performed and reported by the Stat-Site® meter.

The GDS® HemoSite® Test System is a device for in vitro diagnostic use only. The GDS® HemoSite® Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® Meter.

The HemoSite® Test Cards are dry-chemistry Test Cards that contain chemicals which react and produce color when hemoglobin is present. The Stat-Site® Meter is a reflectance colorimeter that reads color intensity. A Test Module is provided with each box of Test Cards. The Test-Module contains all current calibration information for the specific lot of reagent. The Test Module and Test Cards are coded to each other, and the Stat-Site® Meter will only operate if they are properly matched. HemoSite® Test Cards are dry reagent cards based on the azidemethemoglobin method. When a drop of whole blood is applied to the top of the Test Card, hemolysis occurs, with the release of hemoglobin. Sodium nitrite converts the hemoglobin to methemoglobin. Sodium azide converts methemoglobin to azidemethemoglobin to produce a brown color that is measured at 580 nm using the Stat-Site® Meter. The Stat-Site® Meter measures the color intensity and calculates the hemoglobin concentration.