FDA.reportPublic FDA data

ARKRAY FACTORY USA, INC.

Matched from indexed company URL: ARKRAY, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18328161832816ARKRAY FACTORY USA, INC.1Y2026-01-018260 NW 27th Street Suite 403 Miami FL US 33122
96114443002807423ARKRAY, INC.1N2026-01-01Yousuien-nai 59 Gansuin-cho, Kamigyo-ku Kyoto JP 602-0008
30113105763011310576ARKRAY INDUSTRY INC.1N2026-01-01Lot 22 Phase 1A, First Philippine Industrial Park, Brgy. Sta. An Sto. Tomas Batangas PH 4234

GUDID Contact Samples#

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

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00015482104658AUTION MAX™ AX-4060 Analyzer - The AUTION MAX AX-4060 urine analyzer, when used with AUTION Sticks 9EB test strips is a fully automated urinalysis system intended for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, turbidity, and color. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders. This system is intended to be used by trained operators in clinical laboratories.1-855-646-3108xx@xx.xx
00015482510060Assure® Control - Control Solution Level 2 & 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. Carton contains 1 each of level 2 00015482510053 and level 3 00015482510077.800-818-8877xx@xx.xx
00015482600013Assure® Titanium Blood Glucose Meter - The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered Assure Titanium Blood Glucose meter, disposable single-use Assure Titanium Blood Glucose Test Strips, Assure Control-Control Solutions (Level 1, 2 and Level 3), Quick Reference Guide and User Manual. Assure Titanium Blood Glucose Test Strips and Assure Control-Control Solutions are not included in the kit package and should be purchased separately.800-818-8877xx@xx.xx
00015482600501Assure® Titanium Blood Glucose Test Strips - The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered Assure Titanium Blood Glucose meter, disposable single-use Assure Titanium Blood Glucose Test Strips, Assure Control-Control Solutions (Level 1, 2 and Level 3), Quick Reference Guide and User Manual. Assure Titanium Blood Glucose Test Strips and Assure Control-Control Solutions are not included in the kit package and should be purchased separately.800-818-8877xx@xx.xx
00015482601003Assure® Titanium Blood Glucose Test Strips - The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered Assure Titanium Blood Glucose meter, disposable single-use Assure Titanium Blood Glucose Test Strips, Assure Control-Control Solutions (Level 1, 2 and Level 3), Quick Reference Guide and User Manual. Assure Titanium Blood Glucose Test Strips and Assure Control-Control Solutions are not included in the kit package and should be purchased separately.800-818-8877xx@xx.xx
04987486001959S.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.9999999999xxx@xxx.xxx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
105281412795006K980908LACTATE PRO SYSTEMKHP1998-09-11
105271208010457K972710QUANTIFY(901)JJW1997-08-15
105271043539879K232416AUTION EYE AI-4510 Urine Particle Analysis SystemLKM2024-05-03
105281043539879K232416AUTION EYE AI-4510 Urine Particle Analysis SystemLKM2024-05-03
105271720872416K230625ReliOn Premier BLU Blood Glucose Monitoring SystemNBW2023-08-10
105271793439056K223453Insulin SyringeFMF2023-03-02
105271391823303K222084OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet PreemieFMK2022-11-02
105271102785653K221970Lancing deviceQRL2022-08-30
105271694283926K221175Multi-Lancet Device 2, ReliOn Premier Lancing DeviceQRL2022-10-17
105281694283926K221175Multi-Lancet Device 2, ReliOn Premier Lancing DeviceQRL2022-10-17
105271981237303K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)QRL2022-07-06
105271665352158K210065Verifine Safety Type Insulin Pen NeedleFMI2021-04-22
105272043990582K210059Promisemed Insulin Pen NeedleFMI2021-07-21
105271469439148K202682Promisemed Triple Safety Pen NeedleFMI2020-11-24
105271749821965K202681Promisemed Covered Safety Pen NeedleFMI2020-12-31
105271182825121K200788Assure Titanium Blood Glucose Monitoring SystemPZI2022-05-23
105281182825121K200788Assure Titanium Blood Glucose Monitoring SystemPZI2022-05-23
105271953779755K193514AUTION MAX AX-4060 Urinalysis SystemJIL2023-04-13
105281953779755K193514AUTION MAX AX-4060 Urinalysis SystemJIL2023-04-13
105271821357670K192220ReliOn Premier Classic Blood Glucose Monitoring SystemNBW2019-12-13
105271803067905K191853Dual-Safety Pen NeedleFMI2019-09-05
105271754003651K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceGJS2019-02-21
105271502615381K181273GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring SystemNBW2018-11-01
105271506168625K171982DROPLET PEN NEEDLEFMI2018-03-21
105271273801238K170614CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring SystemNBW2017-10-19
105271746403176K170064GLUCOCARD W Blood Glucose Monitoring SystemNBW2017-08-16
105281746403176K170064GLUCOCARD W Blood Glucose Monitoring SystemNBW2017-08-16
105272031694356K162822ADAMS A1c HA-8180V, CALIBRATOR 80PDJ2017-06-29
105282031694356K162822ADAMS A1c HA-8180V, CALIBRATOR 80PDJ2017-06-29
105271457885034K162180Disposable Insulin SyringeFMF2016-12-29
105271142440492K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedleFMI2017-05-11
105271620191276K160062AUTION ELEVEN Semi-Automated Urinalysis SystemJIL2016-10-07
105281620191276K160062AUTION ELEVEN Semi-Automated Urinalysis SystemJIL2016-10-07
105271304842442K153537Sol-M Insulin Syringe, Sol-M TB SyringeFMF2016-06-17
105271031437459K151164Assure Prism multi Blood Glucose Monitoring SystemNBW2015-08-07
105271275755391K143437Droplet Pen NeedlesFMI2015-06-25
105271448442989K142336GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring SystemCGA2014-09-17
105281448442989K142336GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring SystemCGA2014-09-17
105271889606129K142262AUTION CHECK PLUSJJW2015-04-10
105281889606129K142262AUTION CHECK PLUSJJW2015-04-10
105271912531238K142035GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEMNBW2014-09-05
105281912531238K142035GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEMNBW2014-09-05
105271375780860K141759OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERSMMK2014-10-24
105271952052423K132681SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGEMEG2014-05-22
105271080215669K130281OAK RIDGE PRODUCTS SHARP CONTAINERMMK2013-06-21
105271292823352K124021ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEMCGA2014-06-30
105281292823352K124021ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEMCGA2014-06-30
105272001029771K121456AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROLKQO2013-02-01
105282001029771K121456AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROLKQO2013-02-01
105271763665667K121133CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEMNBW2012-07-10
105271334907831K120759CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTIONCGA2012-06-05
105271630766703K120351CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CANBW2012-05-03
105271763835998K113098AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS IIINBW2012-01-17
105271709661067K112755ABACUS 5GKZ2012-03-27
105271399744657K111534ABACUS 3CPGKZ2012-08-02
105271641705879K110709ARK CARE DIABETES MANAGMENT SYSTEMNBW2011-05-19
105271663717747K103011ULTICARE SAFETY INSULIN SYRINGEMEG2011-02-02
105271259734516K093819ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)NBW2010-06-09
105281259734516K093819ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)NBW2010-06-09
105271734320881K093098AUTION MAX MODEL AX-4030 URINALYSIS SYSTEMKQO2009-12-23
105281734320881K093098AUTION MAX MODEL AX-4030 URINALYSIS SYSTEMKQO2009-12-23
105271466259110K092104ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEMCGA2009-11-24
105281466259110K092104ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEMCGA2009-11-24
105271866396844K091102ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMSCGA2009-10-23
105281866396844K091102ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMSCGA2009-10-23
105271719115104K090332ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001NBW2009-08-14
105271263468748K083468CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)NBW2009-02-10
105272068103172K082417GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110CGA2008-10-21
105282068103172K082417GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110CGA2008-10-21
105272030727668K073416ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEMCGA2008-06-13
105282030727668K073416ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEMCGA2008-06-13
105272021214952K070088ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEMNBW2007-02-16
105271165850451K053401SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTSCIC2006-03-24
105281165850451K053401SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTSCIC2006-03-24
105271629098844K051648SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTSCGS2006-01-31
105281629098844K051648SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTSCGS2006-01-31
105271116720016K051432SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTSCIG2005-06-17
105281116720016K051432SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTSCIG2005-06-17
105271510844567K050790SPOTCHEM II LDH TESTCFH2005-06-06
105281510844567K050790SPOTCHEM II LDH TESTCFH2005-06-06
105271111514405K050652SPOTCHEM II CREATININE, AMYLASE & ALP TESTSCGX2005-04-06
105281111514405K050652SPOTCHEM II CREATININE, AMYLASE & ALP TESTSCGX2005-04-06
105271984754746K050077SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTSCIC2005-02-15
105281984754746K050077SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTSCIC2005-02-15
105271310964465K042443SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANELCHH2004-11-24
105281310964465K042443SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANELCHH2004-11-24
105271340966382K041881ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100CGA2005-03-25
105271701712399K041427THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTSCGA2004-11-24
105281701712399K041427THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTSCGA2004-11-24
105271212193818K040332POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERJJF2004-06-16
105281212193818K040332POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERJJF2004-06-16
105271582000525K033851DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)JIL2004-03-02
105271373822217K030600AUTION JET AJ-4270 URINE ANALYZERKQO2003-07-11
105281373822217K030600AUTION JET AJ-4270 URINE ANALYZERKQO2003-07-11
105271485842296K013783AUTION MAX AX-4280 URINALYSIS SYSTEMKQO2002-01-18
105281485842296K013783AUTION MAX AX-4280 URINALYSIS SYSTEMKQO2002-01-18
105271497429461
105271717919840
105281717919840
105271885413902
105281885413902
105271092432340
105271248308981
105281248308981
105271342084490
105281342084490
105271344439273
105281344439273
105271521931170
105281521931170
105271645158488
105281645158488
3316871769341886
3316871863818768
105272059306361
105282059306361

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW182023-08-10
CGA162014-09-17
FMI82021-07-21
KQO82013-02-01
JIL52023-04-13
QRL42022-10-17
CIC42006-03-24
FMF32023-03-02
JJW32015-04-10
LKM22024-05-03
PZI22022-05-23
PDJ22017-06-29
MMK22014-10-24
MEG22014-05-22
GKZ22012-08-02
CGS22006-01-31
CIG22005-06-17
CFH22005-06-06
CGX22005-04-06
CHH22004-11-24
JJF22004-06-16
FMK12022-11-02
GJS12019-02-21
KHP11998-09-11

PMN#

GUDID#

AUTION MAX™ AX-4060 Analyzer - The AUTION MAX AX-4060 urine analyzer, when used with AUTION Sticks 9EB test strips is a fully automated urinalysis system intended for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, turbidity, and color. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders. This system is intended to be used by trained operators in clinical laboratories.

ARKRAY USA, INC.

2025-11-07

Assure® Titanium Blood Glucose Test Strips - The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered Assure Titanium Blood Glucose meter, disposable single-use Assure Titanium Blood Glucose Test Strips, Assure Control-Control Solutions (Level 1, 2 and Level 3), Quick Reference Guide and User Manual. Assure Titanium Blood Glucose Test Strips and Assure Control-Control Solutions are not included in the kit package and should be purchased separately.

ARKRAY USA, INC.

2025-09-15

Assure® Titanium Blood Glucose Test Strips - The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered Assure Titanium Blood Glucose meter, disposable single-use Assure Titanium Blood Glucose Test Strips, Assure Control-Control Solutions (Level 1, 2 and Level 3), Quick Reference Guide and User Manual. Assure Titanium Blood Glucose Test Strips and Assure Control-Control Solutions are not included in the kit package and should be purchased separately.

ARKRAY USA, INC.

2025-09-15

Assure® Titanium Blood Glucose Test Strips - The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered Assure Titanium Blood Glucose meter, disposable single-use Assure Titanium Blood Glucose Test Strips, Assure Control-Control Solutions (Level 1, 2 and Level 3), Quick Reference Guide and User Manual. Assure Titanium Blood Glucose Test Strips and Assure Control-Control Solutions are not included in the kit package and should be purchased separately.

ARKRAY USA, INC.

2025-09-15

Assure® Titanium Blood Glucose Test Strips - The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered Assure Titanium Blood Glucose meter, disposable single-use Assure Titanium Blood Glucose Test Strips, Assure Control-Control Solutions (Level 1, 2 and Level 3), Quick Reference Guide and User Manual. Assure Titanium Blood Glucose Test Strips and Assure Control-Control Solutions are not included in the kit package and should be purchased separately.

ARKRAY USA, INC.

2025-09-15

GLUCOCARD® W Blood Glucose Test Strips - GLUCOCARD W Blood Glucose Test Strips are for use with the GLUCOCARD W blood glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the palm. Alternative site testing (AST) should only be used during steady-state blood glucose conditions. The GLUCOCARD W blood glucose monitoring system is intended for self-testing outside the body (in vitro) by people with diabetes as an aid to monitor the effectiveness of diabetes control. This system is not intended for use on neonates, and it is not for the diagnosis or screening of diabetes.

ARKRAY USA, INC.

2019-04-01

AUTION MAX™ AX-4060 Analyzer - The AUTION MAX AX-4060 urine analyzer, when used with AUTION Sticks 9EB test strips is a fully automated urinalysis sytem intended for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, turbidity, and color. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders. This system is intended to be used by trained operators in clinical laboratories.

ARKRAY USA, INC.

2024-12-02

AUTION EYE™ AI-4510 Analyzer - The AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use. AUTION EYE AI-4510 is intended for the quantitative measurement of red blood cells (RBC), white blood cells (WBC) and squamous epithilial cells (SQEC), the semi-quantitative measurement of bacteria (BACT) and crystals (CRYS) and the qualitative measurement of white blood cell clumps (WBCC), non-squamous epithilial cells (NSE), hyaline casts (HYAL), non-hyaline casts (NHC), yeast (YST), mucus (MUCS) and sperm (SPRM) in urine samples.

ARKRAY USA, INC.

2024-12-02

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