ARKRAY FACTORY USA, INC.

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• xxx.xxx

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• AUTION EYE AI-4510 Urine Particle Analysis System

  2024-05-03

  Arkray, Inc.

• AUTION MAX AX-4060 Urinalysis System

  2023-04-13

  Arkray, Inc.

• Multi-Lancet Device 2, ReliOn Premier Lancing Device

  2022-10-17

  Arkray, Inc.

• Assure Titanium Blood Glucose Monitoring System

  2022-05-23

  Arkray, Inc.

• GLUCOCARD® W Onyx Blood Glucose Monitoring System

  2019-04-10

  ARKRAY Factory, Inc.

• GLUCOCARD W Blood Glucose Monitoring System

  2017-08-16

  ARKRAY FACTORY, INC.

• ADAMS A1c HA-8180V, CALIBRATOR 80

  2017-06-29

  Arkray Factory, Inc.

• AUTION ELEVEN Semi-Automated Urinalysis System

  2016-10-07

  ARKRAY, Inc.

• GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System

  2014-09-17

  ARKRAY FACTORY INC.

• GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM

  2014-09-05

  ARKRAY FACTORY INC.

• ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM

  2014-06-30

  ARKRAY FACTORY INC.

• AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL

  2013-02-01

  ARKRAY, INC.

• ARK CARE DIABETES MANAGMENT SYSTEM

  2011-05-19

  ARKRAY Factory USA, Inc.

• ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)

  2010-06-09

  ARKRAY Factory USA, Inc.

• AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM

  2009-12-23

  ARKRAY, INC.

• ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM

  2009-11-24

  ARKRAY Factory USA, Inc.

• ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS

  2009-10-23

  ARKRAY Factory USA, Inc.

• POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM

  2009-10-09

  ARKRAY Factory USA, Inc.

• ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001

  2009-08-14

  ARKRAY Factory USA, Inc.

• GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110

  2008-10-21

  ARKRAY Factory USA, Inc.

• ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM

  2008-06-13

  ARKRAY Factory USA, Inc.

• SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS

  2006-03-24

  ARKRAY, INC.

• SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS

  2006-01-31

  ARKRAY, INC.

• SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS

  2005-06-17

  ARKRAY, INC.

• SPOTCHEM II LDH TEST

  2005-06-06

  ARKRAY, INC.

• SPOTCHEM II CREATININE, AMYLASE & ALP TESTS

  2005-04-06

  ARKRAY, INC.

• SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS

  2005-02-15

  ARKRAY, INC.

• THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS

  2004-11-24

  ARKRAY, INC.

• SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL

  2004-11-24

  ARKRAY, INC.

• POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER

  2004-06-16

  ARKRAY, INC.

• ARKIT HBA1C

  2003-09-02

  ARKRAY, INC.

• POCKETCHEM UA AUTION STICKS 10TA

  2002-09-17

  ARKRAY, INC.

GUDID#

• AUTION™ Sheath Solution - 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.

  Arkray USA, Inc.

  2016-09-23

• AUTION™ Staining Solution BAC - 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.

  Arkray USA, Inc.

  2016-09-23

• AUTION™ Staining Solution SED - 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.

  Arkray USA, Inc.

  2016-09-23

• AUTION™ Diluent BAC - 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.

  Arkray USA, Inc.

  2016-09-23

• AUTION™ Diluent SED - 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.

  Arkray USA, Inc.

  2016-09-23

• Aution™ AU Control Solution - 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.)

  Arkray USA, Inc.

  2018-09-25

• AUTION™ Uriflet 9HA Test Strips - Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine.

  Arkray USA, Inc.

  2016-09-23

• Calibrator 80 - 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.

  Arkray USA, Inc.

  2017-12-08

• DILUENT 80 - 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.

  Arkray USA, Inc.

  2018-02-08

• ADAMS™ A1c HA-8180V (UL) Analyzer - 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).

  Arkray USA, Inc.

  2017-12-08

• S.G. Calibrator H - 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.

  Arkray USA, Inc.

  2017-04-12

• GLUCOCARD® Vital™ Blood Glucose Monitoring System - Retail: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU

  Arkray USA, Inc.

  2016-09-23

• GLUCOCARD® Vital™ Blood Glucose Monitoring System - DME: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU

  Arkray USA, Inc.

  2016-09-23

• GLUCOCARD® Expression™ Blood Glucose Monitoring System - Retail: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU

  Arkray USA, Inc.

  2016-09-23

• GLUCOCARD® Expression™ Blood Glucose Monitoring System - DME: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU

  Arkray USA, Inc.

  2016-09-23

• GLUCOCARD® Shine XL Blood Glucose Monitoring System - Startup Portable Blood Glucose Meter System. Includes: blood glucose meter, test strips, IFU

  Arkray USA, Inc.

  2017-09-12

• GLUCOCARD® Shine Blood Glucose Monitoring System - Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU

  Arkray USA, Inc.

  2016-09-23

• Assure® Control - Control Solution Level 3 - For use with the Assure Titanium Blood Glucose Monitoring System. Assure Control-Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly.

  Arkray USA, Inc.

  2019-04-01

• Assure® Control - Control Solution Level 2 - For use with the Assure Titanium Blood Glucose Monitoring System. Assure Control-Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly.

  Arkray USA, Inc.

  2019-04-01

• Assure® Control - Control Solution Level 1 - For use with the Assure Titanium Blood Glucose Monitoring System. Assure Control-Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly.

  Arkray USA, Inc.

  2019-04-01

• Assure® ID Safety Pen Needles, 30G x 8mm Sample 10's - Insulin Safety Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the safety shield automatically covers the needle to minimize the risk of accidental needle sticks.

  Arkray USA, Inc.

  2020-01-14

• Assure® ID Safety Pen Needles, 30G x 5mm Sample 10's - Insulin Safety Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the safety shield automatically covers the needle to minimize the risk of accidental needle sticks.

  Arkray USA, Inc.

  2020-01-14

• Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 10's - Assure ID DUO-Shield Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawl from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks.

  Arkray USA, Inc.

  2020-01-21

• Assure® ID DUO-Shield Safety Pen Needle 5mm x 30g 10's - Assure ID DUO-Shield Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawl from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks.

  Arkray USA, Inc.

  2020-01-21

• AUTION Check Plus Controls - 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.

  Arkray USA, Inc.

  2020-02-26

• Assure® Dose Normal (Level 1) Control Solution - Assure® Dose Normal (Level 1) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Mailer packaged with CS insert.)

  Arkray USA, Inc.

  2020-02-28

• Assure® Dose Normal (Level 1) Control Solution - Assure® Dose Normal (Level 1) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Mailer packaged with logbook and CS insert.)

  Arkray USA, Inc.

  2020-02-28

• ARK Care® VITA Patient Mobile Application - ARK Care VITA is a patient mobile application of the ARK Care Advance Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes.

  Arkray USA, Inc.

  2020-03-12

• ReliOn™ Life Patient Mobile Application - ReliOn Life is a patient mobile application of the ARK Care Advance Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes.

  Arkray USA, Inc.

  2020-03-12

• ARK Care® Advance Diabetes Management System - ARK Care Advance is a Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes.

  Arkray USA, Inc.

  2020-03-12

• Assure® Dose Normal/High Control Solution - Assure Dose Normal (Level 1), High (Level 2) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Primary UPC# 015482500061 is used as the assigned UDI for the Class I device.)

  Arkray USA, Inc.

  2019-01-15

• GLUCOCARD® Vital™ Blood Glucose Meter - GLUCOCARD Vital Meter Institutional multi-pack (4 GLUCOCARD Vital meter kits PN 760020)

  Arkray USA, Inc.

  2022-06-17

• Assure® Prism Multi Blood Glucose Meter - Assure Prism Meter Institutional multi-pack (4 Assure Prism meter kits PN 530001)

  Arkray USA, Inc.

  2022-06-17

• Assure® Platinum Blood Glucose Meter - Assure Platinum Meter Institutional multi-pack (4 Assure Platinum meter kits PN 500001)

  Arkray USA, Inc.

  2022-06-17

• AUTION™ Sticks 9EB Test Strips - Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine.

  Arkray USA, Inc.

  2016-09-23

• Aution™ Hybrid AU-4050 Chemical Analyzer - he AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (CHM) is an automated urine analyzer intended for the in vitro measurement of the following parameters: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The chemistry module is intended for use with the Uriflet S 9HA multi-parameter urine chemistry test strips. The flow cytometry module (FCM) is an automated urine particle analyzer intended to analyze the following parameters in urine samples: Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria and flags the presence of the following: Pathological Casts, Crystals, Sperm, Small Round Cells, Yeast Like Cells, and Mucus. The AUTION HYBRID AU-4050 is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

  Arkray USA, Inc.

  2017-02-06

• AUTION™ MAX AX-4030 Analyzer - 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.

  Arkray USA, Inc.

  2016-09-23

• ARKRAY Multi-let 2 Lancing Device - 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.

  Arkray USA, Inc.

  2018-09-24

• TechLITE® Lancets, 28g - TechLITE Lancets 28g 100's. The lancet is intended for capillary blood sampling.

  Arkray USA, Inc.

  2018-09-24

• SPOTCHEM™ II Basic Panel 2 - Strip description for the invitro quantitative determination of ALP, AST, and ALT activity, and total bilirubin and total protein concentration in human plasma from whole blood samples

  Arkray USA, Inc.

  2016-09-23

80 records. Showing 1-40. Next