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 00015482771119 77111 Strip Description:  For the in vitro quantitative determination of ALT (alanine Strip Description:  For the in vitro quantitative determination of ALT (alanine aminotransferease or glutamic pyruvic transaminase) activity in human plasma from whole blood samples. CGA GLUCOSE OXIDASE, GLUCOSE SPOTCHEM™ II ALT / GPT
22 00015482761103 761100 Portable Blood Glucose Meter with Test Strips NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER 2 GLUCOCARD® Vital™ BLOOD GLUCOSE METER
23 00015482760205 760020 Portable Blood Glucose Meter NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER 2 GLUCOCARD® Vital™ BLOOD GLUCOSE METER
24 00015482760014 760001 Portable Blood Glucose Meter NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER 2 GLUCOCARD® Vital™ BLOOD GLUCOSE METER
25 00015482570101 570001 Portable Blood Glucose Meter NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER GLUCOCARD® EXPRESSION Blood Glucose Monitoring System
26 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
27 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
28 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
29 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
30 00015482530501 530050 / 530100 Blood Glucose Test Strips CGA GLUCOSE OXIDASE, GLUCOSE ASSURE® PRISM MULTI BLOOD GLUCOSE TEST STRIPS
31 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
32 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
33 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
34 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
35 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
36 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
37 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
38 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
39 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
40 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
41 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
42 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
43 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
44 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
45 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
46 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
47 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
48 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
49 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
50 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
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