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ARKRAY USA, INC.

Last updated May 24, 2026

What ARKRAY USA, INC. makes

The company manufactures home-use glucose monitoring systems, including blood glucose meters and associated reagents such as control solutions and calibrators. It also produces insulin delivery devices like safety pen needles, metered-delivery hypodermic syringes, and basic insulin syringes, as well as single-use blood lancing devices. Laboratory urine analysers and glycated haemoglobin (HbA1c) test reagents are part of its portfolio, alongside concentrated washing solutions for device maintenance.

These products are regulated under FDA pathways, including 510(k) clearances and De Novo classifications, with devices classified as either Class I or Class II. The company’s devices are listed in the FDA’s 510(k) and UDI registries, and the manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: xxx.xxx
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)566-8558
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 008171162

Catalogue (195)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
Glucocard® 01 Blood Glucose Meter	741100	FDA UDI	Class II	Active
Assure® ID DUO PRO Safety Pen Needles 31gx5mm 100's	277531	FDA UDI	Class II	Active
S.G. Calibrator H	100672	FDA UDI	Class I	Active
Assure® Prism Control Solution	530006	FDA UDI	Class I	Active
Assure® ID Safety Pen Needles, 30G x 5mm Sample 10's	275030	FDA UDI	Class II	Active
ASSURE® ID INSULIN SAFETY SYRINGE .3mL 29G x 1/2"	250293	FDA UDI	Class II	Active
Assure® ID DUO-Shield Safety Pen Needle 5mm x 30g 10's	273530	FDA UDI	Class II	Active
Concentrated Washing Solution 3	101687	FDA UDI	Class I	Active
SPOTCHEM™ EZ Analyzer	18310	FDA UDI	Class II	Unknown
GLUCOCARD® Shine XL Blood Glucose Monitoring System	542110	FDA UDI	Class II	Active
SPOTCHEM™ II Inorganic Phosphorous	77118	FDA UDI	Class II	Unknown
Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 100's	272830	FDA UDI	Class II	Active
TechLITE PLUS PEN NEEDLES	234232	FDA UDI	Class II	Active
ADAMS™ A1c HA-8180V (UL) Analyzer	100675	FDA UDI	Class II	Active
TechLITE Insulin Syringes 0.5mL 30G x 1/2" (12mm)	260303	FDA UDI	Class II	Active
GLUCOCARD® Expression™ Level 2 Control Solution	570007	FDA UDI	Class II	Active
AUTION EYE™ Control Solution H/L	108157	FDA UDI	Class I	Active
Assure® Prism Multi Blood Glucose Meter	530001	FDA UDI	Class II	Active
SPOTCHEM™ II Fructosamine	77117	FDA UDI	Class II	Unknown
Assure® ID Safety Pen Needle 5mm x 31g 100's	275131	FDA UDI	Class II	Active
Assure® Lance Plus Safety Lancets	990125	FDA UDI	Class II	Active
AUTION EYE™ Calibrator Focus/Calibrator	108159	FDA UDI	Class I	Active
Assure® Prism Multi Blood Glucose Test Strips	530050 / 530100	FDA UDI	Class II	Active
Glucocard® 01 Blood Glucose Test Strips	720050	FDA UDI	Class II	Active
ASSURE® Prism Blood Glucose Test Strips	532050	FDA UDI	Class II	Active
AUTION™ Staining Solution SED	73809	FDA UDI	Class I	Active
Assure® Dose Normal (Level 1) Control Solution	502004	FDA UDI	Class I	Active
Spotchem™ Ii Ldh	77120	FDA UDI	Class II	Unknown
Calibrator 80	103400	FDA UDI	Class II	Active
ASSURE® ID Insulin 0.5cc Safety Syringe	210295	FDA UDI	Class II	Unknown
Assure® SD Sharps Container	245003	FDA UDI	Class II	Active
Assure® Dose Normal (Level 1) Control Solution	500005	FDA UDI	Class I	Active
AUTION™ Staining Solution BAC	73810	FDA UDI	Class I	Active
GLUCOCARD® EXPRESSION Blood Glucose Monitoring System	570001	FDA UDI	Class II	Active
GLUCOCARD® Shine Express Blood Glucose Monitoring System	544110	FDA UDI	Class II	Active
SPOTCHEM™ II Total Protein	77108	FDA UDI	Class II	Unknown
GLUCOCARD® Shine Blood Glucose Monitoring System	541100	FDA UDI	Class II	Active
ReliOn™ Life Patient Mobile Application	Ver 1.3.	FDA UDI	Class I	Unknown
GLUCOCARD® Vital™ BLOOD GLUCOSE TEST STRIPS	760050	FDA UDI	Class II	Active
TechLITE PEN NEEDLES	238131	FDA UDI	Class II	Active
Assure® Slide Pill Swallowing Aid zero	1000003	FDA UDI	Class I	Unknown
TechLITE Insulin Syringes 0.3mL 31G x 5/16" (8mm)	260311	FDA UDI	Class II	Active
GLUCOCARD® Shine Level 1 Control Solution	540005	FDA UDI	Class I	Active
TechLITE Insulin Syringes 0.5mL 30G x 5/16" (8mm)	260304	FDA UDI	Class II	Active
TechLITE PEN NEEDLES	235131	FDA UDI	Class II	Active
Assure® Control - Control Solution Level 3	510007	FDA UDI	Class I	Active
TechLITE Insulin Syringes 0.5mL 31G x 5/16" (8mm)	260312	FDA UDI	Class II	Active
Concentrated Washing Solution 3	79053	FDA UDI	Class I	Active
TechLITE® Lancets	880125	FDA UDI	Class II	Active
GLUCOCARD® Expression™ Blood Glucose Monitoring System	571188	FDA UDI	Class II	Unknown

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

ARKRAY USA, INC. has three recall records in the FDA database, all initiated between October 18, 2007, and March 24, 2010, with each listed as terminated. The recalls were due to labeling issues: one involved incorrect control ranges on test strip bottles, another included mislabeled code numbers on meter kits and test strip vials, and the third addressed an incorrect listing of reagents on a bottle carton for Hypoguard DiaScreen 4-way pH 100 strips.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Mar 24, 2010	Z-2634-2010	—	terminated	This recall has been initiated due to a labeling issue with the Hypoguard DiaScreen 4-way pH 100 strips. The front and back panel of the bottle carton lists five reagents when it should only list four reagents. The Ketone reagent should not be included on the label. The test strips contained in the bottle and all other labeling are correct and properly align with 4pH part number D11400 listed on
Nov 16, 2007	Z-0699-2008	—	terminated	Mislabeling: incorrect control range-The Level 1 control solution range printed on the 50-count test strip bottles is incorrect. The range printed on the bottle is 62-54 when it should be 62-94.
Oct 18, 2007	Z-0458-2008	—	terminated	Mis-labeled/coded strips : Meter kits from this lot contain mislabeled 10-count test strip vials. The code number printed on the Advance Micro-draw 10-count test strip bottle is incorrect. The code number on the vial is 867 when it should be 687. The 687-labeled code chip contains the correct calibration information for the "867" test strips, so the meter will function properly and give accurat