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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
TechLITE PEN NEEDLES	236131	FDA UDI	Class II	Active
AUTION Check Plus Controls	102478	FDA UDI	Class I	Active
Eluent 80a	103395	FDA UDI	Class II	Active
GLUCOCARD® Expression™ Level 1 Control Solution	570005	FDA UDI	Class II	Active
TechLITE Insulin Syringes 0.3mL 30G x 1/2" (12mm)	260301	FDA UDI	Class II	Active
Assure® Titanium Blood Glucose Test Strips	600050	FDA UDI	Class II	Active
ASSURE® ID Insulin 1cc Safety Syringe	210291	FDA UDI	Class II	Unknown
Assure® Lance Safety Lancets	980125	FDA UDI	Class II	Active
AUTION EYE™ Sheath Solution - 10L Bottle	108155	FDA UDI	Class I	Active
AUTION™ Diluent SED	73807	FDA UDI	Class I	Active
Assure® Titanium Blood Glucose Test Strips	600100	FDA UDI	Class II	Active
GLUCOCARD® EXPRESSION Blood Glucose Monitoring System	571100	FDA UDI	Class II	Active
GLUCOCARD® Vital™ BLOOD GLUCOSE METER	760020	FDA UDI	Class II	Active
Eluent 80b	103396	FDA UDI	Class II	Active
ASSURE® ID TB SAFETY SYRINGE 1mL 25G x 1"	251251	FDA UDI	Class II	Active
Assure® Prism Multi Blood Glucose Meter	531177	FDA UDI	Class II	Unknown
SPOTCHEM™ II HDL-Cholesterol	77122	FDA UDI	Class I	Unknown
TechLITE Insulin Syringes 0.5mL 29G x 1/2" (12mm)	260292	FDA UDI	Class II	Active
AUTION™ Sticks 9EB - Test Strips	110734	FDA UDI	Class I	Active
GLUCOCARD® Vital™ BLOOD GLUCOSE METER	760001	FDA UDI	Class II	Active
TechLITE PEN NEEDLES	238132	FDA UDI	Class II	Active
Assure® Platinum Blood Glucose Meter	501177	FDA UDI	Class II	Unknown
Assure® Lance Safety Lancets	980225	FDA UDI	Class II	Active
Spotchem™ Ii Ggt	77114	FDA UDI	Class I	Unknown
ASSURE® ID Safety Syringe 1mL 29G x 1/2"	250291	FDA UDI	Class II	Active
TechLITE PEN NEEDLES	232929	FDA UDI	Class II	Active
TechLITE Insulin Syringes 0.3mL 31G x 15/64" (6mm)	260314	FDA UDI	Class II	Active
ASSURE® ID INSULIN SAFETY SYRINGE .5mL 31G x 5/16"	250315	FDA UDI	Class II	Active
TechLITE Insulin Syringes 0.3mL 29G x 1/2" (12mm)	260291	FDA UDI	Class II	Active
GLUCOCARD® Shine Connex Blood Glucose Monitoring System	543110	FDA UDI	Class II	Active
GLUCOCARD® W Blood Glucose Monitoring System	511100	FDA UDI	Class II	Unknown
TechLITE® Lancets, 28g	880128	FDA UDI	Class II	Active
SPOTCHEM™ II Basic Panel 2	77127	FDA UDI	Class II	Unknown
Spotchem™ Ii Cpk	77112	FDA UDI	Class II	Unknown
TechLITE PEN NEEDLES	230929	FDA UDI	Class II	Active
Assure® ID DUO PRO Safety Pen Needles 31gx5mm Sample 10's	277031	FDA UDI	Class II	Active
Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 10's	273830	FDA UDI	Class II	Active
GLUCOCARD® Vital™ BLOOD GLUCOSE TEST STRIPS	762050	FDA UDI	Class II	Active
SPOTCHEM™ II Uric Acid	77102	FDA UDI	Class II	Unknown
SPOTCHEM™ II Lipid Panel	77123	FDA UDI	Class I	Unknown
GLUCOCARD® 01 Control	720005	FDA UDI	Class I	Active
Assure® ID INSULIN SAFETY SYRINGE 0.5mL 31G x 6mm	253315	FDA UDI	Class II	Active
TechLITE Insulin Syringes 0.3mL 30G x 5/16" (8mm)	260302	FDA UDI	Class II	Active
Assure® ID INSULIN SAFETY SYRINGE 1mL 31G x 6mm	253311	FDA UDI	Class II	Active
Assure® ID DUO-Shield Safety Pen Needle 5mm x 30g 100's	272530	FDA UDI	Class II	Active
TechLITE PEN NEEDLES	234932	FDA UDI	Class II	Active
Assure® ID PRO Safety Pen Needles 30gx5mm 100's	276530	FDA UDI	Class II	Active
Spotchem™ Ii Ast / Got	77110	FDA UDI	Class II	Unknown
Assure® Dose Normal/High Control Solution	500006	FDA UDI	Class I	Active
ASSURE® ID INSULIN SAFETY SYRINGE .3mL 31G x 5/16"	250313	FDA UDI	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