BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    ARKRAY, INC.

    Reg #: 9611444 · FEI: 3002807423 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    33
    Establishment Types
    1
    Classifications
    24

    Registration Details

    Registration Name
    ARKRAY, INC.
    Registration Number
    9611444
    FEI Number
    3002807423
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Yousuien-nai, 59 Gansuin-cho,
    City
    Kamigyo-ku Kyoto
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K092104

    Owner / Operator

    Firm Name
    ARKRAY FACTORY USA, Inc.
    Operator Number
    8030316
    Address
    8260 NW 27th Street, Suite 403
    City
    Miami
    State
    FL
    Postal Code
    33122
    Country
    US

    Products

    Device Name Product Code
    Glucose Oxidase, Glucose CGA
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    System, Test, Blood Glucose, Over The Counter NBW
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Blood, Occult, Colorimetric, In Urine JIO
    Test, Urine Leukocyte LJX
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Automated Urinalysis System KQO
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Refractometer For Clinical Use JRE
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Urinalysis Controls (Assayed And Unassayed) JJW
    General Purpose Reagent PPM
    Calibrator, Secondary JIT
    Assay, Glycosylated Hemoglobin LCP
    Hemoglobin A1c Test System PDJ
    Instrumentation, High Pressure Liquid Chromatography LDM
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Prescription Use Blood Glucose Meter For Near-Patient Testing PZI
    Counter, Urine Particle LKM

    Proprietary Names

    Assure Platinum BGM System AUTION Sticks 10EA Test Strips AUTION ELEVEN AE-4022 Semi-Automated Urinalysis System AUTION EYE Control Solution AUTION EYE Sheath Solution AUTION EYE Calibrator Concentrated Washing Solution 3 ReliOn Prime BGM System GLUCOCARD Vital BGM System GLUCOCARD Vital Blood Glucose Test Strips AUTION MAX AX-4030 AUTION Sticks 9EB AUTION CHECK Plus ADAMS A1c HA-8180V Calibrator 80 COLUMN UNIT 80; ELUENT 80A; ELUENT 80B; ELUENT 80CV; Hemolysis Washing Solution 80H; Control Dilution Set 80 Assure Control Control Solution GLUCOCARD 01 SENSOR PLUS Test Strips GLUCOCARD 01 Blood Glucose Monitoring System ReliOn Confirm Blood Glucose Monitoring System ReliOn Confirm/Micro Plus Blood Glucose Test Strips SillHa paper Test Strip Kit SillHa LH-4912 Oral Wellness System AUTION MAX AX-4060 Urinalysis System AUTOMATED URINALYSIS SYSTEM AX-4280 ReliOn Premier Lancing Device Multi-Lancet Device 2 GLUCOCARD 01-mini ReliOn micro S.G. Calibrator H Assure Titanium Blood Glucose Monitoring System AUTION EYE AI-4510

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility