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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)

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Device	Model / Reference	Registries	Class	Status
SPOTCHEM™ II Amylase	77113	FDA UDI	Class II	Unknown
Assure® Lance Safety Lancets	980228	FDA UDI	Class II	Active
Spotchem™ Ii Bun	77105	FDA UDI	Class I	Unknown
GLUCOCARD® Vital™ BLOOD GLUCOSE TEST STRIPS	760010	FDA UDI	Class II	Active
TechLITE PEN NEEDLES	230129	FDA UDI	Class II	Active
AUTION MAX™ AX-4060 Analyzer	110732	FDA UDI	Class II	Active
Aution™ Hybrid AU-4050 Chemical Analyzer	14603	FDA UDI	Class I	Active
GLUCOCARD® Expression™ Blood Glucose Monitoring System	571199	FDA UDI	Class II	Unknown
SPOTCHEM™ II Calcium	77107	FDA UDI	Class I	Unknown
Assure® Dose Normal (Level 1) Control Solution	502005	FDA UDI	Class I	Active
SPOTCHEM™ II Creatinine	77116	FDA UDI	Class II	Unknown
Spotchem™ Ii Alt / Gpt	77111	FDA UDI	Class II	Unknown
Assure® SD Sharps Container	245004	FDA UDI	Class II	Active
AUTION™ MAX AX-4022 Analyzer	102974	FDA UDI	Class I	Active
ASSURE® ID INSULIN SAFETY SYRINGE 1mL 31G x 5/16"	250311	FDA UDI	Class II	Active
AUTION™ Sticks 9EB Test Strips	73627	FDA UDI	Class I	Active
TechLITE PEN NEEDLES	236132	FDA UDI	Class II	Active
ARKRAY Multi-let 2 Lancing Device	660016	FDA UDI	Class II	Active
SPOTCHEM™ II Total Bilirubin	77106	FDA UDI	Class II	Unknown
ASSURE® ID TB SAFETY SYRINGE 1mL 25G x 5/8"	251252	FDA UDI	Class II	Active
TechLITE Insulin Syringes 0.5mL 31G x 15/64" (6mm)	260315	FDA UDI	Class II	Active
TechLITE PEN NEEDLES	234132	FDA UDI	Class II	Active
AUTION™ Uriflet 9HA Test Strips	73521	FDA UDI	Class I	Active
ASSURE® ID TB SAFETY SYRINGE 1mL 27G x 1/2"	251273	FDA UDI	Class II	Active
GLUCOCARD® Shine XL Blood Glucose Monitoring System	542199	FDA UDI	Class II	Active
GLUCOCARD® EXPRESSION Blood Glucose Test Strips	572050	FDA UDI	Class II	Active
Assure® Platinum BLOOD GLUCOSE METER	500001	FDA UDI	Class II	Active
Assure® SD Sharps Container	245001	FDA UDI	Class II	Active
GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS	540010	FDA UDI	Class II	Active
GLUCOCARD® EXPRESSION Blood Glucose Test Strips	570010	FDA UDI	Class II	Active
Assure® ID Safety Pen Needle 8mm x 30g 100's	278130	FDA UDI	Class II	Active
Assure® Control - Control Solution Level 2	510005	FDA UDI	Class I	Active
Assure® Titanium Blood Glucose Meter	600001	FDA UDI	Class II	Active
TechLITE Insulin Syringes 1mL 29G x 1/2" (12mm)	260293	FDA UDI	Class II	Active
ARK Care® Advance Diabetes Management System	Ver 2.0.	FDA UDI	Class I	Unknown
Assure® ID Safety Pen Needles, 30G x 8mm Sample 10's	278030	FDA UDI	Class II	Active
ASSURE® ID TB SAFETY SYRINGE 1mL 31G x 5/16"	251316	FDA UDI	Class II	Active
GLUCOCARD® W Blood Glucose Test Strips	512050	FDA UDI	Class II	Unknown
Assure® Lance Safety Lancets	980121	FDA UDI	Class II	Active
ARK Care® VITA Patient Mobile Application	Ver 1.3.	FDA UDI	Class I	Unknown
GLUCOCARD® Vital™ Blood Glucose Monitoring System	761199	FDA UDI	Class II	Unknown
TechLITE PEN NEEDLES	238931	FDA UDI	Class II	Active
TechLITE Insulin Syringes 1mL 30G x 5/16" (8mm)	260306	FDA UDI	Class II	Active
Assure® Platinum BLOOD GLUCOSE TEST STRIPS	500050 500100	FDA UDI	Class II	Active
Ferrara Blood Glucose Monitoring System, Model 631100	K063068	FDA 510(k)	Class II	Active

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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