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ARKRAY USA, INC.

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GLUCOCARD® Vital™ Blood Glucose Monitoring System
ARKRAY USA, INC.
Retail: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU
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GLUCOCARD® Vital™ Blood Glucose Monitoring System
ARKRAY USA, INC.
DME: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU
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GLUCOCARD® Vital™ Blood Glucose Meter
ARKRAY USA, INC.
GLUCOCARD Vital Meter Institutional multi-pack (4 GLUCOCARD Vital meter kits PN 760020)
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GLUCOCARD® Expression™ Blood Glucose Monitoring System
ARKRAY USA, INC.
Retail: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU
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GLUCOCARD® Expression™ Blood Glucose Monitoring System
ARKRAY USA, INC.
DME: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU
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GLUCOCARD® Shine XL Blood Glucose Monitoring System
ARKRAY USA, INC.
Startup Portable Blood Glucose Meter System. Includes: blood glucose meter, test strips, IFU
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GLUCOCARD® Shine Blood Glucose Monitoring System
ARKRAY USA, INC.
Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU
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Assure® Prism Multi Blood Glucose Meter
ARKRAY USA, INC.
Assure Prism Meter Institutional multi-pack (4 Assure Prism meter kits PN 530001)
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Assure® Platinum Blood Glucose Meter
ARKRAY USA, INC.
Assure Platinum Meter Institutional multi-pack (4 Assure Platinum meter kits PN 500001)
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AUTION™ Sheath Solution
ARKRAY USA, INC.
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.
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AUTION™ Staining Solution BAC
ARKRAY USA, INC.
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.
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AUTION™ Staining Solution SED
ARKRAY USA, INC.
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.
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AUTION™ Diluent BAC
ARKRAY USA, INC.
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.
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AUTION™ Diluent SED
ARKRAY USA, INC.
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.
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Aution™ AU Control Solution
ARKRAY USA, INC.
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.)
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AUTION™ Uriflet 9HA Test Strips
ARKRAY USA, INC.
Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine.
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Calibrator 80
ARKRAY USA, INC.
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.
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DILUENT 80
ARKRAY USA, INC.
These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. This product dilutes commercially available freeze-dried controls and dilutes white blood samples.
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HEMOLYSIS WASHING SOLUTION 80H
ARKRAY USA, INC.
These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. This product dilutes whole blood samples and is used to wash the sample tubes.
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ELUENT 80CV
ARKRAY USA, INC.
These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. These products are used to elute and remove hemoglobin in the column in order of binding strength.
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ELUENT 80B
ARKRAY USA, INC.
These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. These products are used to elute and remove hemoglobin in the column in order of binding strength.
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ELUENT 80A
ARKRAY USA, INC.
These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. These products are used to elute and remove hemoglobin in the column in order of binding strength.
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AUTION Check Plus Controls
ARKRAY USA, INC.
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.)
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ADAMS™ A1c HA-8180V (UL) Analyzer
ARKRAY USA, INC.
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).
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S.G. Calibrator H
ARKRAY USA, INC.
The S.G. Calibrator H is used to calibrate specific gravity on the AUTION HYBRID AU-4050, AUTION MAX AX-4030 and AUTION MAX AX-4280 Urine Analyzers. The calibration is scheduled to occur monthly or as needed.
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Assure® Lance Plus Safety Lancets
ARKRAY USA, INC.
Assure Lance Plus Safety Lancets 30g 100's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.
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Assure® Lance Plus Safety Lancets
ARKRAY USA, INC.
Assure Lance Plus Safety Lancets 25g 100's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.
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Assure® Lance Safety Lancets
ARKRAY USA, INC.
Assure Lance Safety Lancets 28g 30ct. Single-use disposable blood lancet should be used for assisted blood drawn by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.
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Assure® Lance Safety Lancets
ARKRAY USA, INC.
Assure Lance Safety Lancets 21g 100's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.
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Assure® Lance Safety Lancets
ARKRAY USA, INC.
Assure Lance Safety Lancets 28g 200's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.
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Assure® Lance Safety Lancets
ARKRAY USA, INC.
Assure Lance Safety Lancets 21g 200's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.
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Assure® Lance Safety Lancets
ARKRAY USA, INC.
Assure Lance Safety Lancets 28g 100's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.
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Assure® Lance Safety Lancets
ARKRAY USA, INC.
Assure Lance Safety Lancets 25g 100's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.
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Assure® Lance Safety Lancets
ARKRAY USA, INC.
Assure Lance Safety Lancets 28g 10's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.
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TechLITE® Lancets
ARKRAY USA, INC.
TechLITE Lancets 28g 100's. Load lancet into lancing device and twist off protective cap. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container. (Primary UPC# 015482880187; Shipper UPC# 015482882846 are used as the assigned UDI for the Class I device.)
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TechLITE® Lancets
ARKRAY USA, INC.
TechLITE Lancets 25g 100's. Load lancet into lancing device and twist off protective cap. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container. (Primary UPC# 015482880125; Shipper UPC# 015482882549 are used as the assigned UDI for the Class I device.)
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Concentrated Washing Solution 3
ARKRAY USA, INC.
A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.
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SPOTCHEM™ II Basic Panel 2
ARKRAY USA, INC.
Strip Description: For the in vitro quantitative determination of ALP, AST, and ALT activity, and total bilirubin and total protein concentration in human plasma from whole blood samples.
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SPOTCHEM™ II Basic Panel 1
ARKRAY USA, INC.
Strip Description: For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine concentration in human plasma from whole blood samples.
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SPOTCHEM™ II Lipid Panel
ARKRAY USA, INC.
Strip Description: For the in vitro quantitative determination of HDL-cholesterol, total cholesterol, and triglyceride in human plasma from whole blood samples.
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SPOTCHEM™ II HDL-Cholesterol
ARKRAY USA, INC.
Strip Description: For the in vitro quantitative determination of HDL-Cholesterol in human plasma from whole blood samples.
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SPOTCHEM™ II LDH
ARKRAY USA, INC.
Strip Description: For the in vitro quantitative determination of lactate dehydrogenase (LDH) activity in human plasma from whole blood samples.
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SPOTCHEM™ II Magnesium
ARKRAY USA, INC.
Strip Description: For the in vitro quantitative determination of magnesium concentration in human plasma from whole blood samples.
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SPOTCHEM™ II Inorganic Phosphorous
ARKRAY USA, INC.
Strip Description: For the in vitro quantitative determination of inorganic phosphorus concentration in human plasma from whole blood samples.
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SPOTCHEM™ II Fructosamine
ARKRAY USA, INC.
Strip Description: For the in vitro quantitative determination of fructosamine in human plasma from whole blood samples.
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SPOTCHEM™ II Creatinine
ARKRAY USA, INC.
Strip Description: For the in vitro quantitative determination of creatinine concentration in human plasma from whole blood samples.
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SPOTCHEM™ II ALP
ARKRAY USA, INC.
Strip Description: For the in vitro quantitative determination of ALP (alkaline phosphatase) activity in human plasma from whole blood samples.
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SPOTCHEM™ II GGT
ARKRAY USA, INC.
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.
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SPOTCHEM™ II Amylase
ARKRAY USA, INC.
Strip Description: For the in vitro quantitative determination of amylase concentration in human plasma from whole blood samples.
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SPOTCHEM™ II CPK
ARKRAY USA, INC.
Strip Description: For the in vitro quantitative determination of creatine kinase (creatine phosphokinase or CPK) activity in human plasma from whole blood samples.
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