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ARKRAY USA, INC.

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Company Name
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SPOTCHEM™ II ALT / GPT
ARKRAY USA, INC.
Strip description for the invitro quantitative determination of ALT(alanine aminotransferease or glutamic pyruvic transaminase) activity in human plasma from whole blood samples
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SPOTCHEM™ II AST / GOT
ARKRAY USA, INC.
Strip description for the invitro quantitative determination of AST (aspartate aminotransferase or glutamic oxaloacetic transaminase, GOT) activity in human plasma from whole blood samples
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SPOTCHEM™ II Albumin
ARKRAY USA, INC.
Strip description for the invitro quantitative determination of albumin concentration in human plasma from whole blood samples
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SPOTCHEM™ II Total Protein
ARKRAY USA, INC.
Strip description for the invitro quantitative determination of total protein in human plasma from whole blood samples
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SPOTCHEM™ II Calcium
ARKRAY USA, INC.
Strip description for the invitro quantitative determination of calcium concentration in human plasma from whole blood samples
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SPOTCHEM™ II Total Bilirubin
ARKRAY USA, INC.
Strip description for the invitro quantitative determination of total bilirubin concentration in human plasma from whole blood samples
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SPOTCHEM™ II BUN
ARKRAY USA, INC.
Strip description for the invitro quantitative determination of blood urea nitrogen in human plasma from whole blood samples
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SPOTCHEM™ II Triglycerides
ARKRAY USA, INC.
Strip is for invitro quantitative determination of triglycerides in human plasma from whole blood samples
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SPOTCHEM™ II Total Cholesterol
ARKRAY USA, INC.
Strip description for the invitro quantitative determination of total cholesterol in human plasma from whole blood samples
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SPOTCHEM™ II Uric Acid
ARKRAY USA, INC.
Strip description for the invitro quantitative determination of uric acid concentration in human plasma from whole blood samples
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SPOTCHEM™ II Glucose
ARKRAY USA, INC.
Strip description for the invitro quantitative determination of glucose in human plasma from whole blood samples
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GLUCOCARD® Vital™ BLOOD GLUCOSE TEST STRIPS
ARKRAY USA, INC.
Blood Glucose Test Strips
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GLUCOCARD® Vital™ BLOOD GLUCOSE METER
ARKRAY USA, INC.
Portable Blood Glucose Meter with Test Strips
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GLUCOCARD® Vital™ BLOOD GLUCOSE TEST STRIPS
ARKRAY USA, INC.
Blood Glucose Test Strips
0
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GLUCOCARD® Vital™ BLOOD GLUCOSE METER
ARKRAY USA, INC.
Portable Blood Glucose Meter
0
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GLUCOCARD® Vital™ BLOOD GLUCOSE TEST STRIPS
ARKRAY USA, INC.
Blood Glucose Test Strips
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GLUCOCARD® Vital™ BLOOD GLUCOSE METER
ARKRAY USA, INC.
Portable Blood Glucose Meter
0
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GLUCOCARD® 01 BLOOD GLUCOSE METER
ARKRAY USA, INC.
Portable Blood Glucose Meter with Test Strips
0
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GLUCOCARD® 01 BLOOD GLUCOSE TEST STRIPS
ARKRAY USA, INC.
Blood Glucose Test Strips
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GLUCOCARD® 01 Control
ARKRAY USA, INC.
GLUCOCARD 01 Control contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 015482740061 is used as the assigned UDI for the Class I device.)
0
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GLUCOCARD® 01 BLOOD GLUCOSE METER
ARKRAY USA, INC.
Portable Blood Glucose Meter
0
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GLUCOCARD® 01 BLOOD GLUCOSE METER
ARKRAY USA, INC.
Portable Blood Glucose Meter
0
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AUTION™ Sticks 9EB 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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AUTION™ Sticks 10EA Test Strips
ARKRAY USA, INC.
Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine.
0
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GLUCOCARD® 01 BLOOD GLUCOSE TEST STRIPS
ARKRAY USA, INC.
Blood Glucose Test Strips
0
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GLUCOCARD® 01 Control
ARKRAY USA, INC.
GLUCOCARD 01 Control contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 015482720056 is used as the assigned UDI for the Class I device.)
0
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ARKRAY Multi-let 2 Lancing Device
ARKRAY USA, INC.
A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device.
0
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TechLITE Insulin Syringes 1mL 31G x 15/64" (6mm)
ARKRAY USA, INC.
TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
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TechLITE Insulin Syringes 0.5mL 31G x 15/64" (6mm)
ARKRAY USA, INC.
TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
0
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TechLITE Insulin Syringes 0.3mL 31G x 15/64" (6mm)
ARKRAY USA, INC.
TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
0
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TechLITE Insulin Syringes 1mL 31G x 5/16" (8mm)
ARKRAY USA, INC.
TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
0
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TechLITE Insulin Syringes 0.5mL 31G x 5/16" (8mm)
ARKRAY USA, INC.
TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
0
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TechLITE Insulin Syringes 0.3mL 31G x 5/16" (8mm)
ARKRAY USA, INC.
TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
0
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TechLITE Insulin Syringes 1mL 30G x 5/16" (8mm)
ARKRAY USA, INC.
TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
0
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TechLITE Insulin Syringes 1mL 30G x 1/2" (12mm)
ARKRAY USA, INC.
TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
0
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TechLITE Insulin Syringes 0.5mL 30G x 5/16" (8mm)
ARKRAY USA, INC.
TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
0
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TechLITE Insulin Syringes 0.5mL 30G x 1/2" (12mm)
ARKRAY USA, INC.
TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
0
-
TechLITE Insulin Syringes 0.3mL 30G x 5/16" (8mm)
ARKRAY USA, INC.
TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
0
-
TechLITE Insulin Syringes 0.3mL 30G x 1/2" (12mm)
ARKRAY USA, INC.
TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
0
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TechLITE Insulin Syringes 1mL 29G x 1/2" (12mm)
ARKRAY USA, INC.
TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
0
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TechLITE Insulin Syringes 0.5mL 29G x 1/2" (12mm)
ARKRAY USA, INC.
TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
0
-
TechLITE Insulin Syringes 0.3mL 29G x 1/2" (12mm)
ARKRAY USA, INC.
TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
0
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GLUCOCARD® EXPRESSION Blood Glucose Test Strips
ARKRAY USA, INC.
Blood Glucose Test Strips
0
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GLUCOCARD® EXPRESSION Blood Glucose Monitoring System
ARKRAY USA, INC.
Portable Blood Glucose Meter
0
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LANZO Lancing Device
ARKRAY USA, INC.
A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device.
0
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GLUCOCARD® EXPRESSION Blood Glucose Monitoring System
ARKRAY USA, INC.
Portable Blood Glucose Meter
0
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GLUCOCARD® Expression™ Level 2 Control Solution
ARKRAY USA, INC.
GLUCOCARD Expression Level 2 Control Solution. The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. (Primary UPC# 015482570071 is used as the assigned UDI for the Class I device.)
0
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GLUCOCARD® EXPRESSION Blood Glucose Test Strips
ARKRAY USA, INC.
Blood Glucose Test Strips
0
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GLUCOCARD® EXPRESSION Blood Glucose Test Strips
ARKRAY USA, INC.
Blood Glucose Test Strips
0
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GLUCOCARD® Expression™ Level 1 Control Solution
ARKRAY USA, INC.
GLUCOCARD Expression Level 1 Control Solution. The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. (Primary UPC# 015482570002 is used as the assigned UDI for the Class I device.)