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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
GLUCOCARD® Shine Level 2 Control Solution	540007	FDA UDI	Class I	Active
TechLITE Pen Needle 4mm x 32g Sample 10's	234032	FDA UDI	Class II	Active
Assure® ID Safety Pen Needle 5mm x 30g 100's	275130	FDA UDI	Class II	Active
Glucocard® 01 Blood Glucose Meter	740001	FDA UDI	Class II	Active
AUTION™ Sticks 10EA Test Strips	73526	FDA UDI	Class I	Active
SPOTCHEM™ II Albumin	77109	FDA UDI	Class II	Unknown
Assure® Platinum BLOOD GLUCOSE TEST STRIPS	500010	FDA UDI	Class II	Active
Glucocard® 01 Blood Glucose Test Strips	740050	FDA UDI	Class II	Active
Assure® Lance Plus Safety Lancets	990130	FDA UDI	Class II	Active
GLUCOCARD® Vital™ Blood Glucose Monitoring System	761188	FDA UDI	Class II	Active
GLUCOCARD® EXPRESSION Blood Glucose Test Strips	570050	FDA UDI	Class II	Active
AUTION™ Sheath Solution	73811	FDA UDI	Class I	Active
AUTION™ Diluent BAC	73808	FDA UDI	Class I	Active
GLUCOCARD® Shine Blood Glucose Monitoring System	540001	FDA UDI	Class II	Active
TechLITE PEN NEEDLES	232129	FDA UDI	Class II	Active
Assure® Platinum	502030	FDA UDI	Class II	Active
Eluent 80cv	103397	FDA UDI	Class II	Active
SPOTCHEM™ II Glucose	77101	FDA UDI	Class II	Unknown
Glucocard® 01 Blood Glucose Meter	740020	FDA UDI	Class II	Active
SPOTCHEM™ II Magnesium	77119	FDA UDI	Class I	Unknown
Diluent 80	103399	FDA UDI	Class II	Active
SPOTCHEM™ II Total Cholesterol	77103	FDA UDI	Class I	Unknown
AUTION EYE™ AI-4510 Analyzer	108861	FDA UDI	Class II	Active
GLUCOCARD® Vital™ Blood Glucose Meter	761177	FDA UDI	Class II	Unknown
SPOTCHEM™ II Basic Panel 1	77126	FDA UDI	Class II	Unknown
Assure® Lance Safety Lancets	980028	FDA UDI	Class II	Active
TechLITE Insulin Syringes 1mL 31G x 5/16" (8mm)	260313	FDA UDI	Class II	Active
Assure® SD Sharps Container	245002	FDA UDI	Class II	Active
Assure® Lance Safety Lancets	980328	FDA UDI	Class II	Active
GLUCOCARD® 01 Control	740006	FDA UDI	Class I	Active
ASSURE® ID TB SAFETY SYRINGE 1mL 28G x 1/2"	251285	FDA UDI	Class II	Active
Hemolysis Washing Solution 80h	103398	FDA UDI	Class II	Active
Spotchem™ Ii Alp	77115	FDA UDI	Class II	Unknown
Assure® Slide Pill Swallowing Aid forte	1000002	FDA UDI	Class I	Unknown
Assure® Lance Safety Lancets	980128	FDA UDI	Class II	Active
LANZO Lancing Device	570015	FDA UDI	Class II	Active
SPOTCHEM™ II Triglycerides	77104	FDA UDI	Class I	Unknown
TechLITE Insulin Syringes 1mL 31G x 15/64" (6mm)	260316	FDA UDI	Class II	Active
TechLITE PEN NEEDLES	235931	FDA UDI	Class II	Active
Assure® SD Sharps Container	243001	FDA UDI	Class II	Active
TechLITE® Lancets, 26g	880126	FDA UDI	Class II	Active
GLUCOCARD® Vital™ BLOOD GLUCOSE METER	761100	FDA UDI	Class II	Active
GLUCOCARD® Shine Blood Glucose Monitoring System	541199	FDA UDI	Class II	Unknown
TechLITE Insulin Syringes 1mL 30G x 1/2" (12mm)	260305	FDA UDI	Class II	Active
Assure® Control - Control Solution Level 1	510004	FDA UDI	Class I	Active
Aution™ AU Control Solution	73806	FDA UDI	Class I	Active
ARK Care®	Version 2.5.3.	FDA UDI	Class I	Active
GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS	542050	FDA UDI	Class II	Active
ASSURE® ID Safety Syringe .5mL 29G x 1/2"	250295	FDA UDI	Class II	Active
AUTION™ MAX AX-4030 Analyzer	14505	FDA UDI	Class I	Active

Related Companies

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Authorities

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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