| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00657498300039 | G3000-CONTCUV | G3000-CONTCUV | The HemoPoint® H2 system is intended for the quantitative determination of hemog The HemoPoint® H2 system is intended for the quantitative determination of hemoglobin (Hgb) in whole blood of adults, infants, and children in a professional point-of-care setting. It consists of a dedicated photometer and individual, single-use microcuvettes filled with reagents. | GKR | System, Hemoglobin, Automated | 2 | HemoPoint H2 |
| 2 | 00657498002261 | 7014-204 | 7014-204 | Blood Glucose Control Solution is intended for use with EKF Diagnostic’s Blood G Blood Glucose Control Solution is intended for use with EKF Diagnostic’s Blood Glucose Test Strip. It is used to check that the meter and test strips are working together properly. It is important to do control solution tests routinely to ensure getting accurate results. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Blood Glucose Control Solution |
| 3 | 00657498001776 | 20270479 | 20270479 | For use to wash the ISE module and sample probe. | Sirrus® ISE Wash Solution | |||
| 4 | 00657498001530 | S0370-600 | S0370-600 | For the Quantitative Colorimetric Determination of Iron in Serum. | JIY | Photometric Method, Iron (Non-Heme) | 1 | Sirrus® Total Iron LiquiColor® |
| 5 | 00657498001509 | S0250-750 | S0250-750 | For the Quantitative Colorimetric Determination of Total Protein in Serum. | CEK | Biuret (Colorimetric), Total Protein | 2 | Sirrus® Total Protein LiquiColor® |
| 6 | 00657498001479 | S0190-750 | S0190-750 | For the Quantitative Determination of Bicarbonate (CO2) in Serum and Plasma. | KHS | Enzymatic, Carbon-Dioxide | 2 | Sirrus® Bicarbonate (CO2) LiquiColor® |
| 7 | 00657498001356 | 1430-050 | 1430-050 | A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG) in Urine. | JHI | Visual, Pregnancy Hcg, Prescription Use | TRUE® 20 hCG | |
| 8 | 00657498001141 | 1012-030 | 1012-030 | Quantitative-Enzymatic-Colorimetric Determination of Total and HDL Cholesterol i Quantitative-Enzymatic-Colorimetric Determination of Total and HDL Cholesterol in Serum or Plasma. | CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | Cholesterol Standard (200 mg/dL) |
| 9 | 00657498001127 | 0550-605 | 0550-605 | For use as a multi-calibrator serum to calibrate different chemistry reagent use For use as a multi-calibrator serum to calibrate different chemistry reagent used in manual and automated clinical chemistry methods. | JIX | Calibrator, Multi-Analyte Mixture | 2 | Ser-T-Cal Multicalibrator |
| 10 | 00657498001042 | 2200-225 | 2200-225 | For the Quantitative Enzymatic-Colorimetric Determination of Triglycerides in Se For the Quantitative Enzymatic-Colorimetric Determination of Triglycerides in Serum or Plasma. | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | Triglyceride LiquiColor® (Mono) |
| 11 | 00657498001035 | 2200-430 | 2200-430 | For the Quantitative Enzymatic-Colorimetric Determination of Triglycerides in Se For the Quantitative Enzymatic-Colorimetric Determination of Triglycerides in Serum or Plasma. | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | Triglyceride LiquiColor® (Mono) |
| 12 | 00657498000861 | 2370-401 | 2370-401 | Stanbio Glycated Serum Protein (GSP) Control Kit is intended to be used for qual Stanbio Glycated Serum Protein (GSP) Control Kit is intended to be used for quality control procedures in examining the accuracy and precision of Stanbio Glycated Serum Protein LiquiColor® Assay (REF 2350-062). | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Glycated Serum Protein Bi-Level Control Set |
| 13 | 00657498000847 | 2350-062 | 2350-062 | Stanbio Glycated Serum Protein (GSP) Assay in conjunction with Stanbio Glycated Stanbio Glycated Serum Protein (GSP) Assay in conjunction with Stanbio Glycated Serum Protein calibrator, are intended for the quantitative determination of glycated serum proteins (GSP; glycated albumin; fructosamine) in serum. The measurement of glycated serum proteins is useful for monitoring diabetic patients. | LCP | Assay, Glycosylated Hemoglobin | 2 | Glycated Serum Protein (GSP) LiquiColor® |
| 14 | 00657498000533 | 2460-605 | 2460-605 | For Use as Controls in Quantitative Procedures for Acetaminophen, Salicylate, an For Use as Controls in Quantitative Procedures for Acetaminophen, Salicylate, and ß-Hydroxybutyrate. | DIF | Drug Mixture Control Materials | 1 | TDM/B-Hydroxybutyrate Tri-Level Controls |
| 15 | 00657498000526 | B2440-180 | B2440-180 | For the Quantitative Determination of ß-Hydroxybutyrate in Serum or Plasma. | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 | Synchron® CX/LX/DX B-Hydroxybutyrate LiquiColor® |
| 16 | 00657498000519 | 2440-058 | 2440-058 | For the Quantitative Determination of ß-Hydroxybutyrate in Human Serum or Plasma. | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 | B-Hydroxybutyrate LiquiColor® |
| 17 | 00657498000489 | 2970-430 | 2970-430 | For the Quantitative Determination of Amylase in Serum and Urine. | JFJ | Catalytic Methods, Amylase | 2 | a-Amylase LiquiColor® |
| 18 | 00657498000120 | 202000 | 202000 | STAT-Site® Diluent is intended to be used with the STAT-Site® M β-HB Test Strips STAT-Site® Diluent is intended to be used with the STAT-Site® M β-HB Test Strips or KetoSite® Test Cards to dilute specimens containing high levels of β-hydroxybutyrate into the test range of 0 – 2 mM. Additionally, the diluent helps to eliminate possible matrix effects caused by interfering substances such as acetoacetate. | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 | STAT-Site Diluent |
| 19 | 00657498000014 | 6300-020 | 6300-020 | For the Qualitative Detection of IgG Antibodies to Helicobacter pylori (H. pylor For the Qualitative Detection of IgG Antibodies to Helicobacter pylori (H. pylori) in Whole blood, Serum or Plasma. | LYR | Helicobacter Pylori | RELY® H.Pylori | |
| 20 | 00657498301654 | 3016-050 | 3016-050 | For the quantitative determination of hemoglobin in capillary, venous or arteria For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood. | GKR | System, Hemoglobin, Automated | HemoPoint® H2 n•x•t Microcuvettes | |
| 21 | 00657498001837 | S0130-600 | S0130-600 | For the Quantitative Determination of Magnesium in Serum, Plasma or Urine. | JGJ | Photometric Method, Magnesium | 1 | Sirrus® Magnesium LiquiColor® |
| 22 | 00657498001561 | S0590-540 | S0590-540 | For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol in Human Serum. | LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | Sirrus® Direct HDL Cholesterol LiquiColor® |
| 23 | 00657498001523 | S0360-200 | S0360-200 | For the Quantitative Determination of Glycohemoglobin (HbA1c) in human blood. | LCP | Assay, Glycosylated Hemoglobin | 2 | Sirrus® Direct Gylcohemoglobin (HbA1c) |
| 24 | 00657498001486 | S0230-600 | S0230-600 | For the Quantitative Colorimetric Determination of Total Bilirubin in Serum and Plasma. | JFM | Enzymatic Method, Bilirubin | 2 | Sirrus® Total Bilirubin LiquiColor® |
| 25 | 00657498001318 | 1230-025 | 1230-025 | For the qualitative determination of human chorionic gonadotropin (hCG) in serum For the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. | JHI | Visual, Pregnancy Hcg, Prescription Use | QuPID® Plus hCG Pregnancy Test | |
| 26 | 00657498001301 | 1170-500 | 1170-500 | Carbon flocculation slide test for the qualitative and quantitative determinatio Carbon flocculation slide test for the qualitative and quantitative determination of reagin antibodies in serum or plasma. | GMQ | Antigens, Nontreponemal, All | 2 | RPR Quicktest |
| 27 | 00657498001295 | 1170-100 | 1170-100 | Carbon flocculation slide test for the qualitative and quantitative determinatio Carbon flocculation slide test for the qualitative and quantitative determination of reagin antibodies in serum or plasma. | GMQ | Antigens, Nontreponemal, All | 2 | RPR Quicktest |
| 28 | 00657498001219 | G428-86 | G428-86 | Use as a control serum to monitor the accuracy and precision of manual and autom Use as a control serum to monitor the accuracy and precision of manual and automated methods used in clinical chemistry. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Ser-T-Fy 2, Level 2 Control |
| 29 | 00657498001066 | 2100-225 | 2100-225 | For the Quantitative Enzymatic- Colorimetric Determination of Triglycerides in S For the Quantitative Enzymatic- Colorimetric Determination of Triglycerides in Serum or Plasma. | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | Triglyceride LiquiColor® |
| 30 | 00657498001059 | 2100-430 | 2100-430 | For the Quantitative Enzymatic- Colorimetric Determination of Triglycerides in S For the Quantitative Enzymatic- Colorimetric Determination of Triglycerides in Serum or Plasma. | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | Triglyceride LiquiColor® |
| 31 | 00657498000809 | 1060-500 | 1060-500 | For the Quantitative Determination of Glucose in Serum or Plasma. | CFR | Hexokinase, Glucose | 2 | Glucose Liqui-UV® |
| 32 | 00657498000632 | 0210-250 | 0210-250 | Quantitative Colorimetric Determination of Chloride in Serum, Plasma, Urine and CSF. | CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 2 | Chloride LiquiColor® |
| 33 | 00657498000236 | 3025-050 | 3025-050 | For the quantitative determination of hemoglobin in capillary, venous or arteria For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood. | GKR | System, Hemoglobin, Automated | n•x•t Microcuvette | |
| 34 | 00657498000168 | 503000 | 503000 | A bi-level reference control intended for use on STAT-Site® and HemoSite® hemogl A bi-level reference control intended for use on STAT-Site® and HemoSite® hemoglobin testing systems, including the STAT-Site® MHgb Test System. | JPK | Mixture, Hematology Quality Control | 2 | STAT-Site Hgb Controls |
| 35 | 00657498000113 | 303500 | 303500 | The STAT-Site® Linearity Check is intended to be used to perform a linearity eva The STAT-Site® Linearity Check is intended to be used to perform a linearity evaluation of the STAT-Site® Mβ-HB Test Strips /KetoSite® Test Cards by making a series of dilutions using STAT-Site® Diluent (Catalog No. 202000). Both the STAT-Site® Mβ-HB Test Strips and KetoSite® Test Cards are used in the measurement of β-hydroxybutyrate with the STAT-Site® Mβ-HB and STAT-Site® Meter. | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 | STAT-Site Linearity Check |
| 36 | 00657498002377 | 3063-006 | 3063-006 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | HGB Controls - High |
| 37 | 00657498002360 | 3063-003 | 3063-003 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | HGB Controls - High |
| 38 | 00657498002216 | 7010-100 | 7010-100 | The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together wi The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes. | LFR | Glucose Dehydrogenase, Glucose | STAT-Site WB Blood Glucose Test Strips | |
| 39 | 00657498002209 | 7010-050 | 7010-050 | The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together wi The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes. | LFR | Glucose Dehydrogenase, Glucose | STAT-Site WB Blood Glucose Test Strips | |
| 40 | 00657498002193 | 7010-025 | 7010-025 | The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together wi The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes. | LFR | Glucose Dehydrogenase, Glucose | STAT-Site WB Blood Glucose Test Strips | |
| 41 | 00657498002131 | 4000-100 | 4000-100 | Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood. | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | Nitro-tab Ketone Tablets | |
| 42 | 00657498002025 | 3060-101N | 3060-101N | A single level reference control intended for use on HemoPoint® H2 Hemoglobin te A single level reference control intended for use on HemoPoint® H2 Hemoglobin testing system. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Hgb Control, Normal |
| 43 | 00657498001905 | 20270476 | 20270476 | Ion-Selective Electrode for the measurement of potassium in serum. | CEM | Electrode, Ion Specific, Potassium | 2 | ISE Potassium Electrode |
| 44 | 00657498001790 | A469-98 | A469-98 | To provide calibration points for the Sodium, Potassium, and Chloride electrodes To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas Chemistry Systems. | JIX | Calibrator, Multi-Analyte Mixture | 2 | Standard 2 |
| 45 | 00657498001752 | 20270477 | 20270477 | The ISE Calibrator 1 for the Sirrus® is an in vitro diagnostic calibrator system The ISE Calibrator 1 for the Sirrus® is an in vitro diagnostic calibrator system intended for use on the Sirrus® Chemistry Analyzer to calibrate the ISE module option for chloride, potassium and sodium. | JIX | Calibrator, Multi-Analyte Mixture | 2 | Sirrus® ISE Calibrator 1 |
| 46 | 00657498001745 | 2211-600 | 2211-600 | For use as a probe cleaner on the Sirrus® Chemistry Analyzer. | Sirrus® Probe Cleaner | |||
| 47 | 00657498001639 | S2200-750 | S2200-750 | For the Quantitative Colorimetric Determination of Triglycerides in Serum and Plasma. | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | Sirrus® Triglyceride LiquiColor® |
| 48 | 00657498001615 | S1060-600 | S1060-600 | For the Quantitative Determination of Glucose in Serum, Plasma, CSF or Urine. | CFR | Hexokinase, Glucose | 2 | Sirrus® Glucose Liqui-UV® |
| 49 | 00657498001257 | 1130-100 | 1130-100 | Latex agglutination slide test for the Qualitative and Semi-quantitative determi Latex agglutination slide test for the Qualitative and Semi-quantitative determination of C-Reactive Protein in non-diluted serum. | DCN | System, Test, C-Reactive Protein | 2 | RaPET® CRP |
| 50 | 00657498001240 | 1130-050 | 1130-050 | Latex agglutination slide test for the Qualitative and Semi-quantitative determi Latex agglutination slide test for the Qualitative and Semi-quantitative determination of C-Reactive Protein in non-diluted serum. | DCN | System, Test, C-Reactive Protein | 2 | RaPET® CRP |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00812137012203 | 4 x 0.5mL | 502-189 | This product is for the purpose of calibrating results in the quantitative deter This product is for the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. | HbA1c Calibrator Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
| 2 | 00812137012166 | L1 x 2 x 0.5mL, L2 x 2 x 0.5mL | 502-156 | This product is for the purpose of monitoring accuracy and precision in the quan This product is for the purpose of monitoring accuracy and precision in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. Throughout the circulatory life of the red cell, Hemoglobin A1c is formed continuously by the adduction of glucose to the N-terminal of the hemoglobin beta chain. This process, which is non-enzymatic, reflects the average exposure of hemoglobin to glucose over an extended period. | HbA1c Control Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
| 3 | 00812137012081 | R1 x 30mL, R2 x 10mL, R3 x 125mL | 501-421 | For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. Th For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. | HbA1c Reagent Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
| 4 | 00811727016164 | 16-H7546-200 | 16-H7546-200 | Pointe HbA1c Reagent packaged for use on the Mindray BA800. 10 x 15ml R1, 5 x 1 Pointe HbA1c Reagent packaged for use on the Mindray BA800. 10 x 15ml R1, 5 x 10ml R2. For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. | Pointe HbA1c Reagent | POINTE SCIENTIFIC, INC. |
| 5 | 00811727015853 | 14-H7546-160 | 14-H7546-160 | Pointe HbA1c Reagent packaged for use on the BS480. 2x60mL, 2x20mL Kit. For the Pointe HbA1c Reagent packaged for use on the BS480. 2x60mL, 2x20mL Kit. For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. | Pointe HbA1c for the BS480 | POINTE SCIENTIFIC, INC. |
| 6 | 00811727015044 | OH546-40 | OH546-40 | Pointe Scientific, Inc. HbA1c Reagent is for the quantitative determination of H Pointe Scientific, Inc. HbA1c Reagent is for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. Packaged for use on Olympus Analyzers. For in vitro diagnostic use only. 2 x 15ml, 1 x 10ml | Pointe Scientific, Inc. HbA1c | POINTE SCIENTIFIC, INC. |
| 7 | 00811727014559 | H7546-CAL | H7546-CAL | Liquid Hemoglobin A1c Calibrator Set, This product is for the purpose of calibra Liquid Hemoglobin A1c Calibrator Set, This product is for the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. Size: 4 x 1 mL | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
| 8 | 00811727014542 | H7546-120 | H7546-120 | Hemoglobin A1c Reagent, for the quantitative determination of Hemoglobin A1c (Hb Hemoglobin A1c Reagent, for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. Size: 1 x 90 mL, 1 x 30 mL | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
| 9 | 00811727014535 | H7546-40 | H7546-40 | Hemoglobin A1c Reagent, for the quantitative determination of Hemoglobin A1c (Hb Hemoglobin A1c Reagent, for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. Size: 1 x 30 mL, 1 x 10 mL. | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
| 10 | 00811727014245 | 13-G7540-STD | 13-G7540-STD | This product is for the purpose of standardizing results obtained from run to ru This product is for the purpose of standardizing results obtained from run to run in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin.1 x 1 ml | Pointe Scientific, Inc. Glyco Standard | POINTE SCIENTIFIC, INC. |
| 11 | 00811727014238 | 13-G7540-RES-120 | 13-G7540-RES-120 | Reagent for the quantitative determination of Glycohemoglobin (HbA1) in blood by Reagent for the quantitative determination of Glycohemoglobin (HbA1) in blood by cation exchange resin. The test is to be used to monitor long-term glucose control in diabetes mellitus.1 x 120 ml | Pointe Scientific, Inc. Glyco Resin | POINTE SCIENTIFIC, INC. |
| 12 | 00811727014221 | 13-G7540-LYS-30 | 13-G7540-LYS-30 | Lyse for the quantitative determination of Glycohemoglobin (HbA1) in blood by ca Lyse for the quantitative determination of Glycohemoglobin (HbA1) in blood by cation exchange resin. The test is to be used to monitor long-term glucose control in diabetes mellitus.1 x 30 ml | Pointe Scientific, Inc. Gyco Lyse | POINTE SCIENTIFIC, INC. |
| 13 | 00811727013569 | 12-H7546-40 | 12-H7546-40 | For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. Th For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. | HbA1c | POINTE SCIENTIFIC, INC. |
| 14 | 00811727013545 | 12-H7541-40 | 12-H7541-40 | For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. Th For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. | HbA1c | POINTE SCIENTIFIC, INC. |
| 15 | 00811727013521 | 12-F7546-55 | 12-F7546-55 | This reagent is intended for the quantitative determination of fructosamine in h This reagent is intended for the quantitative determination of fructosamine in human serum. For in vitro diagnostic use only. | Fructosamine | POINTE SCIENTIFIC, INC. |
| 16 | 00811727011541 | H7541-CTL | H7541-CTL | This product is for the purpose of monitoring accuracy and precision in the quan This product is for the purpose of monitoring accuracy and precision in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. 4 x 0.5ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
| 17 | 00811727011534 | H7541-CAL | H7541-CAL | This product is for the purpose of calibrating results in the quantitative deter This product is for the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. 4 x 0.5ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
| 18 | 00811727011510 | H7541-120 | H7541-120 | Reagent for the quantitative determination of Hemoglobin A1c (HbA1c) in human bl Reagent for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. 1 x 90ml, 1 x 28.5ml, 1 x 1.5ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
| 19 | 00811727011503 | H7541-40 | H7541-40 | Reagent for the quantitative determination of Hemoglobin A1c (HbA1c) in human bl Reagent for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. 1 x 30ml, 1 x 9.5ml, 1 x .5ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
| 20 | 00811727011336 | G7540-2 | G7540-2 | Controls for use in the quantitative determination of human glycohemoglobin (HbA Controls for use in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin.2 x 1.0ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
| 21 | 00811727011329 | G7540-STD | G7540-STD | This product is for the purpose of standardizing results obtained from run to ru This product is for the purpose of standardizing results obtained from run to run in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin.1 x 1.0ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
| 22 | 00811727011312 | G7540-80 | G7540-80 | Test for the quantitative determination of Glycohemoglobin (HbA1) in blood by ca Test for the quantitative determination of Glycohemoglobin (HbA1) in blood by cation exchange resin. The test is to be used to monitor long-term glucose control in diabetes mellitus.80 test | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
| 23 | 00811727011305 | G7540-40 | G7540-40 | Test for the quantitative determination of Glycohemoglobin (HbA1) in blood by ca Test for the quantitative determination of Glycohemoglobin (HbA1) in blood by cation exchange resin. The test is to be used to monitor long-term glucose control in diabetes mellitus.40 test | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
| 24 | 00811727011091 | F7546-CTL | F7546-CTL | These Fructosamine Controls are intended for use in fructosamine test systems to These Fructosamine Controls are intended for use in fructosamine test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.1 For in vitro diagnostic use only. | POINTE SCIENTIFIC Fructosamine Control Set | POINTE SCIENTIFIC, INC. |
| 25 | 00811727011084 | F7546-CAL | F7546-CAL | The Fructosamine calibrator is derived from pooled human serum containing buffer The Fructosamine calibrator is derived from pooled human serum containing buffers, stabilizers and fillers. It is intended for use as a calibrator in the determination of fructosamine test systems to validate performance of the assay. | POINTE SCIENTIFIC Fructosamine Calibrator | POINTE SCIENTIFIC, INC. |
| 26 | 00811727011077 | F7546-110 | F7546-110 | This reagent is intended for the quantitative determination of fructosamine in h This reagent is intended for the quantitative determination of fructosamine in human serum. For in vitro diagnostic use only. | POINTE SCIENTIFIC Fructosamine | POINTE SCIENTIFIC, INC. |
| 27 | 00681131403252 | 3055 | 3055 | The ReliOn A1C Self Test System provides a quantitative measurement of the perce The ReliOn A1C Self Test System provides a quantitative measurement of the percent of glycated hemoglobin levels in capillary (fingerstick) blood samples. The test is for home use to monitor glycemic control in people with diabetes. | ReliOn™ 2CT A1C Meter | WAL-MART STORES, INC. |
| 28 | 00681131078368 | 3055 | 3055 | The ReliOn™ Fast A1C Test provides quantitative measurement of the percent of gl The ReliOn™ Fast A1C Test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples. | ReliOn™ Fast A1C Test | WAL-MART STORES, INC. |
| 29 | 00657498001523 | S0360-200 | S0360-200 | For the Quantitative Determination of Glycohemoglobin (HbA1c) in human blood. | Sirrus® Direct Gylcohemoglobin (HbA1c) | STANBIO LABORATORY, L.P. |
| 30 | 00657498000922 | 0357-201 | 0357-201 | For Use as Human Glycohemoglobin Controls in Quantitative Glycohemoglobin Procedures. | Glycohemoglobin Bi-Level Controls | STANBIO LABORATORY, L.P. |
| 31 | 00657498000915 | P350-050 | P350-050 | For the Quantitative Colorimetric Determination of Glycohemoglobin in Whole Blood. | Glycohemoglobin Pre-Fil | STANBIO LABORATORY, L.P. |
| 32 | 00657498000908 | 0350-060 | 0350-060 | For the Quantitative Colorimetric Determination of Glycohemoglobin in Whole Blood. | Glycohemoglobin | STANBIO LABORATORY, L.P. |
| 33 | 00657498000892 | 0355-201 | 0355-201 | For use as controls in the Quantitative Determination of Hemoglobin (HbA1c) in h For use as controls in the Quantitative Determination of Hemoglobin (HbA1c) in human blood. | Direct Glycohemoglobin (HbA1c) Control Set | STANBIO LABORATORY, L.P. |
| 34 | 00657498000885 | 0365-401 | 0365-401 | For use as a calibrator in the quantitative determination of human Hemoglobin A1 For use as a calibrator in the quantitative determination of human Hemoglobin A1c (HbA1c) in blood by automated immunoassay. | Direct Glycohemoglobin (HbA1c) Calibrator Set | STANBIO LABORATORY, L.P. |
| 35 | 00657498000878 | 0360-040 | 0360-040 | For the Quantitative Determination of Glycohemoglobin (HbA1c) in human blood. | Direct Glycohemoglobin (HbA1c) | STANBIO LABORATORY, L.P. |
| 36 | 00657498000847 | 2350-062 | 2350-062 | Stanbio Glycated Serum Protein (GSP) Assay in conjunction with Stanbio Glycated Stanbio Glycated Serum Protein (GSP) Assay in conjunction with Stanbio Glycated Serum Protein calibrator, are intended for the quantitative determination of glycated serum proteins (GSP; glycated albumin; fructosamine) in serum. The measurement of glycated serum proteins is useful for monitoring diabetic patients. | Glycated Serum Protein (GSP) LiquiColor® | STANBIO LABORATORY, L.P. |
| 37 | 00630414977485 | 10487396 | LCOCVM | Cortisol Sample Diluent CVM - IMMULITE - CONS | IMMULITE® Systems COR Calibration Verification Material Cortisol | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 38 | 00630414596129 | 11097500 | 11097500 | Hemoglobin A1c_3 (A1c_3) Atellica CH - RGT 400T | Atellica CH A1c_3 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 39 | 00630414595580 | 11097637 | 11097637 | Fructosamie (Fruc) Atellica CH - RGT 400T | Atellica CH Fruc | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 40 | 00630414571270 | 10485591 | 10485591 | HbA1c - ADVIA Chem. - RGT - 4x200 tests | ADVIA® Chemistry A1c_3 Hemoglobin A1c Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 41 | 00630414569512 | 10379673 | 10379673 | HbA1c - ADVIA Chem. - RGT - 2x80 tests | ADVIA® Chemistry A1c_3 Hemoglobin A1c Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 42 | 00630414558080 | 10361942 | 4862528 | Lipoprotein - ADVIA Chem. - RGT - 200 tests | ADVIA® Chemistry LP(A) Lipoprotein(a) Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 43 | 00630414558073 | 10361941 | 4862501 | Fructosamine - ADVIA Chem. - RGT - 200 tests | ADVIA® Chemistry FRUC Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 44 | 00630414555140 | 10286032 | 4795367 | HbA1C Denaturant - ADVIA Chem. - CONS - 920mL (for 920 Tests) | ADVIA® Chemistry HbA1c Denaturant Reagent - Manual Pretreat | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 45 | 00630414551364 | 10282969 | 5075US | The DCA Vantage system is a semi-automated, benchtop system. It is designed to q The DCA Vantage system is a semi-automated, benchtop system. It is designed to quantitatively measure the percent of Hemoglobin A1cin blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine. The DCA Vantage system is intended for professional use in a physician’s office or hospital laboratory. Tests performed usingthe DCA Vantage system are intended for in vitro diagnostic use. | DCA Vantage® Analyzer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 46 | 00630414532806 | 10311134 | 5035C | DCA HbA1c Test Kit (monitoring only) - INTL. | DCA™ Systems Hemoglobin A1c Reagent Kit | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 47 | 00630414497105 | 10311161 | 5068A | The DCA™ Hemoglobin A1c Control Kit contains both NORMAL Controls and ABNORMAL C The DCA™ Hemoglobin A1c Control Kit contains both NORMAL Controls and ABNORMAL Controls which are prepared as a stabilized hemolysate from human blood. The DCA Hemoglobin A1c Control Kit has been designed for use with DCA™ Analyzers. | DCA™ Systems Hemoglobin A1c Control Kit | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 48 | 00630414220505 | 11097536 | 11097536 | Enzymatic Hemoglobin A1c_E (A1c_E) Atellica CH - RGT 600T | Atellica CH A1c_E | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 49 | 00630414171142 | 10888741 | 10888741 | A blood collection tube holder; to be used with DCA® Systems HbA1c Reagent Cartridge. | DCA® Systems Hemoglobin A1c capillary holders | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 50 | 00630414002880 | 10721048 | 10721048 | ADVIA A1c_E Pretreatment Solution, 1L | ADVIA Chemistry Enzymatic hemoglobin A1c Pretreatment | SIEMENS HEALTHCARE DIAGNOSTICS INC. |