Other products from "ARKRAY USA, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00015482740504 740050 Blood Glucose Test Strips CGA GLUCOSE OXIDASE, GLUCOSE GLUCOCARD® 01 BLOOD GLUCOSE TEST STRIPS
2 00015482183103 18310 Dry Chemistry Analyzer IVD, semi-automated CGA GLUCOSE OXIDASE, GLUCOSE 2 SPOTCHEM™ EZ Analyzer
3 00015482771195 77119 Strip Description:  For the in vitro quantitative determination of magnesium con Strip Description:  For the in vitro quantitative determination of magnesium concentration in human plasma from whole blood samples. JGJ PHOTOMETRIC METHOD, MAGNESIUM SPOTCHEM™ II Magnesium
4 00015482771089 77108 Strip Description:  For the in vitro quantitative determination of total protein Strip Description:  For the in vitro quantitative determination of total protein in human plasma from whole blood samples. CIX BROMCRESOL GREEN DYE-BINDING, ALBUMIN SPOTCHEM™ II Total Protein
5 00015482771065 77106 Strip Description:  For the in vitro quantitative determination of total bilirub Strip Description:  For the in vitro quantitative determination of total bilirubin concentration in human plasma from whole blood samples. CIX BROMCRESOL GREEN DYE-BINDING, ALBUMIN SPOTCHEM™ II Total Bilirubin
6 00015482771034 77103 Strip Description:  For the in vitro quantitative determination of total cholest Strip Description:  For the in vitro quantitative determination of total cholesterol in human plasma from whole blood samples. CHH ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL SPOTCHEM™ II Total Cholesterol
7 00015482720506 720050 Blood Glucose Test Strips CGA GLUCOSE OXIDASE, GLUCOSE GLUCOCARD® 01 BLOOD GLUCOSE TEST STRIPS
8 00015482540050 540005 GLUCOCARD Shine Level 1 Control Solution contains a specific amount of glucose t GLUCOCARD Shine Level 1 Control Solution contains a specific amount of glucose that is used to check the performance of the meter and test strips. The test results you obtain should fall within the control solution range printed on the vial of test strips. (Primary UPC# 015482540050 is used as the assigned UDI for the Class I device.) JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 GLUCOCARD® Shine Level 1 Control Solution
9 00015482502959 250295 Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries. MEG Syringe, Antistick 2 ASSURE® ID Safety Syringe .5mL 29G x 1/2"
10 00015482275310 275131 Insulin Safety Pen Needle. Intended to be used with a pen injector device for t Insulin Safety Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, Hypodermic, Single Lumen Assure® ID Safety Pen Needle 5mm x 31g 100's
11 00015482129743 102974 Urine Analyzer utilize reflectance technology with  with AUTION Strips reagent t Urine Analyzer utilize reflectance technology with  with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results.  Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity. JMT,JIN,JRE,JIR,JJB,JIO,KQO,CEN,CDM,JIL,LJX DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT),NITROPRUSSIDE, KETONES (URINA DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT),NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.),REFRACTOMETER FOR CLINICAL USE,INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.),AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.),BLOOD, OCCULT, COLORIMETRIC, IN URINE,AUTOMATED URINALYSIS SYSTEM,DYE-INDICATOR, PH (URINARY, NON-QUANT.),DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.),METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE),TEST, URINE LEUKOCYTE 1 AUTION™ MAX AX-4022 Analyzer
12 30015482571994 571199 Retail: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU CGA,NBW GLUCOSE OXIDASE, GLUCOSE,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER 2 GLUCOCARD® Expression™ Blood Glucose Monitoring System
13 30015482571888 571188 DME: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU NBW,CGA SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,GLUCOSE OXIDASE, GLUCOSE 2 GLUCOCARD® Expression™ Blood Glucose Monitoring System
14 04987486738060 73806 Aution AU Control Solution is supplied in 2 different levels (High and Low) and Aution AU Control Solution is supplied in 2 different levels (High and Low) and is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry model. (Primary UPC/EAN-13# 4987486738060 is used as the assigned UDI for the Class I device.) JJW Urinalysis Controls (Assayed And Unassayed) 1 Aution™ AU Control Solution
15 04987486015147 103400 The Calibrator 80 is for the calibration of the ADAMS A1c HA-8180 system used fo The Calibrator 80 is for the calibration of the ADAMS A1c HA-8180 system used for the quantitative determination of Hemoglobin A1c (HbA1c) in human whole blood and hemolysate samples. Bi-level calibrators (low and high) lyophilized calibrator from human-sourced hemoglobin. JIT Calibrator, Secondary 2 Calibrator 80
16 04987486001973 100675 The ADAMS A1c HA-8180V system is intended for the quantitative determination of The ADAMS A1c HA-8180V system is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood and hemolysate samples using Ion Exchange high performance liquid chromatography (HPLC). PDJ Hemoglobin A1c Test System 2 ADAMS™ A1c HA-8180V (UL) Analyzer
17 00015482230296 230129 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
18 00015482571108 571100 Portable Blood Glucose Meter NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER GLUCOCARD® EXPRESSION Blood Glucose Monitoring System
19 00015482771225 77122 Strip Description:  For the in vitro quantitative determination of HDL-Cholester Strip Description:  For the in vitro quantitative determination of HDL-Cholesterol in human plasma from whole blood samples. CHH ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL SPOTCHEM™ II HDL-Cholesterol
20 00015482771201 77120 Strip Description:  For the in vitro quantitative determination of lactate dehyd Strip Description:  For the in vitro quantitative determination of lactate dehydrogenase (LDH) activity in human plasma from whole blood samples. CFH TETRAZOLIUM INT DYE-DIAPHORASE, LACTATE DEHYDROGENASE SPOTCHEM™ II LDH
21 00015482761103 761100 Portable Blood Glucose Meter with Test Strips NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER 2 GLUCOCARD® Vital™ BLOOD GLUCOSE METER
22 00015482760205 760020 Portable Blood Glucose Meter NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER 2 GLUCOCARD® Vital™ BLOOD GLUCOSE METER
23 00015482760014 760001 Portable Blood Glucose Meter NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER 2 GLUCOCARD® Vital™ BLOOD GLUCOSE METER
24 00015482570101 570001 Portable Blood Glucose Meter NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER GLUCOCARD® EXPRESSION Blood Glucose Monitoring System
25 00015482544102 544110 The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for the The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf. NBW System, Test, Blood Glucose, Over The Counter 2 GLUCOCARD® Shine Express Blood Glucose Monitoring System
26 00015482542108 542110 The GLUCOCARD Shine XL Blood Glucose Monitoring System is intended for the quant The GLUCOCARD Shine XL Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf. NBW System, Test, Blood Glucose, Over The Counter 2 GLUCOCARD® Shine XL Blood Glucose Monitoring System
27 00015482541002 541100 The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantita The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes. NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER GLUCOCARD® Shine Blood Glucose Monitoring System
28 00015482540012 540001 The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantita The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes. NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER GLUCOCARD® Shine Blood Glucose Monitoring System
29 00015482530501 530050 / 530100 Blood Glucose Test Strips CGA GLUCOSE OXIDASE, GLUCOSE ASSURE® PRISM MULTI BLOOD GLUCOSE TEST STRIPS
30 00015482502300 502030 N/A Blood Glucose Test Strips. Assure Platinum Test Strips are intended for the qua Blood Glucose Test Strips. Assure Platinum Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood when used with the Assure Platinum Blood Glucose Meter. Testing is done outside the body (in vitro diognostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as a aid to monitor the effectiveness of diabetes control. CGA Glucose Oxidase, Glucose Assure® Platinum
31 00015482232290 232129 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
32 00015482232993 232929 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
33 00015482230999 230929 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
34 00015482238919 238931 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
35 00015482238322 238132 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
36 00015482238315 238131 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
37 00015482236328 236132 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
38 00015482236311 236131 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
39 00015482235918 235931 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
40 00015482235314 235131 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of drugs. FMI Needle, Hypodermic, Single Lumen TechLITE PEN NEEDLES
41 00015482234928 234932 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
42 00015482234324 234132 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
43 00015482145057 14505 Urine Analyzer utilize reflectance technology with  with AUTION Strips reagent t Urine Analyzer utilize reflectance technology with  with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results.  Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity. KQO AUTOMATED URINALYSIS SYSTEM 1 AUTION™ MAX AX-4030 Analyzer
44 30015482542994 542199 Startup Portable Blood Glucose Meter System. Includes: blood glucose meter, te Startup Portable Blood Glucose Meter System. Includes: blood glucose meter, test strips, IFU CGA,NBW Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter 2 GLUCOCARD® Shine XL Blood Glucose Monitoring System
45 30015482541997 541199 Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU CGA,NBW GLUCOSE OXIDASE, GLUCOSE,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER 2 GLUCOCARD® Shine Blood Glucose Monitoring System
46 04987486738107 73810 Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment. KQO AUTOMATED URINALYSIS SYSTEM 1 AUTION™ Staining Solution BAC
47 04987486009801 102478 Aution Check Plus Controls is supplied in 2 different levels (2 bottles x 25mL o Aution Check Plus Controls is supplied in 2 different levels (2 bottles x 25mL of each level per box). They are supplied in liquid form, requiring no pretreatment or dilution. They are prepared by adding various compounds to human urine so that the desired reaction occurs during quality control. Preservatives have been added to prevent bacteria growth. (Primary UPC/EAN-13# 4987486009801 is used as the assigned UDI for the Class I device.) JJW Urinalysis Controls (Assayed And Unassayed) 1 AUTION Check Plus Controls
48 00015482771171 77117 Strip Description:  For the in vitro quantitative determination of fructosamine Strip Description:  For the in vitro quantitative determination of fructosamine in human plasma from whole blood samples. CGA GLUCOSE OXIDASE, GLUCOSE SPOTCHEM™ II Fructosamine
49 00015482771140 77114 Strip Description:  For the in vitro quantitative determination of GGT (y-glutam Strip Description:  For the in vitro quantitative determination of GGT (y-glutamyltransferase or y-glutamyl tanspeptidase, Y-GPT) activity in human plasma from whole blood samples. JPZ COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE SPOTCHEM™ II GGT
50 30015482761999 761199 Retail: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU CGA,NBW GLUCOSE OXIDASE, GLUCOSE,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER 2 GLUCOCARD® Vital™ Blood Glucose Monitoring System
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12 00891237001485 8818 1485 25 ct bottle Blood Glucose Testing Strips for use with Easy Talk or Easy Plus II 25 ct bottle Blood Glucose Testing Strips for use with Easy Talk or Easy Plus II monitoring systems Easy Talk Blood Glucose Testing Strips 25ct HOME AIDE DIAGNOSTICS, INC.
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14 00891237001195 T5D2-00 1195 50ct box of Easy Step blood glucose test strips for use with Easy Step blood glu 50ct box of Easy Step blood glucose test strips for use with Easy Step blood glucose monitoring system Easy Step Blood Glucose Test Strips 50ct HOME AIDE DIAGNOSTICS, INC.
15 EABA40000411 400-0041 400-0041 The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is in The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, amylase, aspartate aminotransferase (AST), calcium, c-reactive protein (CRP), creatine kinase, creatinine, glucose, potassium, sodium, total bilirubin and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. Piccolo AmLyte 13 ABAXIS, INC.
16 EABA40000371 400-0037 400-0037 The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemist The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood or lithium heparinized plasma in a clinical laboratory setting or point-of-care location. Piccolo MetLac 12 Panel ABAXIS, INC.
17 EABA40000351 400-0035 400-0035 The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry an The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), c-reactive protein (CRP), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total protein, blood urea nitrogen (BUN), and uric acid in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. Piccolo BioChemistry Panel Plus ABAXIS, INC.
18 EABA40000341 400-0034 400-0034 The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemis The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of c-reactive protein (CRP), chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. Piccolo MetLyte Plus CRP ABAXIS, INC.
19 EABA40000311 400-0031 400-0031 The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry a The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total carbon dioxide, and blood urea nitrogen in a clinical laboratory setting or point-of-care location. This disc is for testing heparinized plasma and serum, only. Piccolo Basic Metabolic Panel Plus ABAXIS, INC.
20 EABA40000301 400-0030 400-0030 The Piccolo® Lipid Panel Plus, used with the Piccolo® blood chemistry analyzer o The Piccolo® Lipid Panel Plus, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended for the in vitro quantitative determination of total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), triglycerides (TRIG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and glucose (GLU) in capillary (fingerstick) lithium heparinized whole blood, venous lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. From the CHOL, HDL and TRIG determinations, low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL), non-HDL cholesterol, and a total cholesterol/high-density lipoprotein cholesterol ratio (TC/H) are calculated by the analyzer.Lipid measurements are used in the diagnosis and treatment of lipid and lipoprotein disorders, atherosclerosis, various liver and renal diseases, diabetes mellitus, and other diseases involving lipid metabolism or various endocrine disorders.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood (venous or capillary) may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. Piccolo Lipid Panel Plus ABAXIS, INC.
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34 00885502001034 IGM-0008 IGM-G2-103 EasyGluco™G2 Meter Kit U.S. DIAGNOSTICS INC.
35 00885502001003 IGM-0024 G5-103MK INFINITY™ Meter Kit U.S. DIAGNOSTICS INC.
36 00885502000044 IGM-0009 IGM-G3-003 Control™ Starter Kit U.S. DIAGNOSTICS INC.
37 00885502000037 IGM-0008 IGM-G2-101 EasyGluco™G2 Starter Kit U.S. DIAGNOSTICS INC.
38 00885502000006 IGM-0024 G5-003SK INFINITY™ Starter Kit U.S. DIAGNOSTICS INC.
39 00885325001426 343105 Tempo Blood Glucose Test Strip Tempo I-SENS, INC.
40 00885325001419 343104 Tempo Blood Glucose Test Strip Tempo I-SENS, INC.
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42 00885325001310 164284 CareSens N Blood Glucose Monitoring System CareSens N I-SENS, INC.
43 00885325001242 164101 CareSens N Blood Glucose Test Strip CareSens N I-SENS, INC.
44 00885325001105 164303-203 CareSens N Blood Glucose Monitoring System (White) CareSens N I-SENS, INC.
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48 00885325000436 164422 CareSens N POP Blood Glucose Monitoring System CareSens N POP I-SENS, INC.
49 00885325000375 521100 COOL Blood Glucose Monitoring System COOL I-SENS, INC.
50 00885325000054 155104 CareSens N Blood Glucose Test Strip CareSens N (MedPoint Diagnostics) I-SENS, INC.