BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NOVA BIOMEDICAL CORPORATION

    Reg #: 1219029 · FEI: 1219029 · Expires 2026
    View on FDA
    Products
    57
    Proprietary Names
    97
    Establishment Types
    7
    Classifications
    57

    Registration Details

    Registration Name
    NOVA BIOMEDICAL CORPORATION
    Registration Number
    1219029
    FEI Number
    1219029
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    200 Prospect St
    City
    WALTHAM
    State
    MA
    ZIP
    02454
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131703

    Owner / Operator

    Firm Name
    NOVA BIOMEDICAL CORP.
    Operator Number
    1219029
    Address
    200 PROSPECT ST., --
    City
    Waltham
    State
    MA
    Postal Code
    02454
    Country
    US

    Products

    Device Name Product Code
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion Specific, Calcium JFP
    Electrode, Ion-Specific, Chloride CGZ
    Instrument, Hematocrit, Automated GKF
    Controls For Blood-Gases, (Assayed And Unassayed) JJS
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Electrode, Ion Specific, Potassium CEM
    Glucose Oxidase, Glucose CGA
    Calibrator, Multi-Analyte Mixture JIX
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Mixture, Hematology Quality Control JPK
    Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide JKS
    Device, Hematocrit Measuring JPI
    System, Hemoglobin, Automated GKR
    Test, Time, Prothrombin GJS
    Acid, Lactic, Enzymatic Method KHP
    Illuminator System For Blood Products PJF
    Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction JBJ
    Hemoglobinometer GIG
    Urinalysis Controls (Assayed And Unassayed) JJW
    System, Test, Blood Glucose, Over The Counter NBW
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Glucose Dehydrogenase, Glucose LFR
    Test, Lactic Acid, Over The Counter NGD
    Electrode, Ion Specific, Urea Nitrogen CDS
    Cyanomethemoglobin GKK
    Assay, Sulfhemoglobin GJC
    Electrode, Ion Specific, Magnesium CFA
    Calibrator, Pressure, Gas BXX
    Oximeter To Measure Hemoglobin GLY
    Assay, Carboxyhemoglobin GHS
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Electrode, Ion Based, Enzymatic, Creatinine CGL
    Oxyhemoglobin GGZ
    Calibrator For Hemoglobin And Hematocrit Measurement KRZ
    Ldl & Vldl Precipitation, Hdl LBR
    Prescription Use Blood Glucose Meter For Near-Patient Testing PZI
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Assay, Glycosylated Hemoglobin LCP
    Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica JQT
    Ph Rate Measurement, Carbon-Dioxide JFL
    Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use JJC
    Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) JIQ
    Alkaline Picrate, Colorimetry, Creatinine CGX
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Colorimetric Method, Triglycerides JGY
    Diazo Colorimetry, Bilirubin CIG
    Calibrator, Secondary JIT
    Standards And Controls, Hemoglobin, Normal And Abnormal GFS
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Retainer, Matrix JEP
    Uric Acid Test System For At Home Prescription Use PTC
    Assay, Fetal Hemoglobin KQI
    Bilirubin (Total And Unbound) In The Neonate Test System MQM
    Blood, Occult, Enzymatic Method, In Urine JIP

    Proprietary Names

    Stat Profile Prime Nova Chemistry Controls Dimension QuikLYTE Integrated Mutisensor Standard B Dimension QuikLYTE Integrated Multisensor Standard A Nova Stat Profile pHOx Basic Stat Profile pHOx Plus L INTERCEPT Blood System for Platelets Stat Profile Prime Plus Stat Profile Prime ABG Blood Gas Analyzer StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter Stat Profile Prime ABG Analyzer Allegro UACR Controls Nova Stat Profile pHOx Plus StatStrip Xpress Nova 11 Nova 13 Nova Stat Profile pHOx Ultra Nova Stat Profile Critical Care Xpress Nova 12 Nova Stat Profile pHOx Nova Chemistry Linearity Nova Allegro System StatStrip Xpress Glucose Meter Nova StatStrip Nova StatStrip Xpress Nova 1 StatStrip Xpress 2 Glucose Hospital Meter INTERCEPT Blood System for Plasma Nova 14 StatStrip Glucose Hospital Meter System Nova Allegro HbA1c Assay Nova Allegro Analyzer Stat Profile Prime CCS & CCS Comp Nova 16 Nova Allegro UCAR Assay Nova Max One Menarini Glucofix Mio Plus Nova Max Plus Menarini Glucofix Mio Menarini Glucomen Lx Menarini Glyco PC Nova Max Menarini Glucomen Lx Plus Nova Stat Profile Prime ES 53417 Remanufactured Prime ES Comp 53461 Prime Calibrator Cartridge ES Comp 500 Sample 52853 Prime ES Comp 53663 Remanufactured Prime ES Comp w/ Scanner 53653 Prime ES Comp w/ Scanner 53103 Prime Calibrator Cartridge ES Comp 100 Sample 53110 Prime Ampuled Control ES 53102 Prime Calibrator Cartridge ES Comp 300 Sample 42035 Prime Sensor Card ES Comp 53598 Prime Demo Auto QC Cartridge 53600 Prime Demo Calibrator Cartridge 56452 Prime ES Diluent Solution 53460 Prime Calibrator Cartridge ES Comp 400 Sample 54786 Prime Demo Sensor Card ES Comp 53362 Prime Calibrator Cartridge ES Comp 200 Sample 53462 Prime Calibrator Cartridge ES Comp 600 Sample Nova Chemistry Performance Check Solution Nova Glucose Control Solutions Nova 4 Nova StatProfile Critical Care Xpress StatSensor Menarini GlycoPC Nova StatStrip Lactate Nova One Clot Catcher Sample Cup LifeScan OneTouch StatStrip StatStrip Nova Stat Profile pHOx Plus C Nova Co-Oximeter Nova 8 Nova Pro B-Ketone Test Strips Nova StatStrip Xpress Glucose and B-Ketone Meter Nova Pro Glucose and B-Ketone Controls and Linearity Solutions 51184 Menarini Glucofix Mio Premium Nova StatStrip Glucose and B-Ketone Controls and Linearity Solutions StatStrip B-Ketone Test Strips Nova StatStrip Glucose and B-Ketone Meter Nipro StatStrip XP3 Nova Pro Glucose Test Strips Nova Pro Glucose and B-Ketone Meter 51185 Menarini Glucofix Mio Premium Nova 10 Stat Profile Prime ES Comp Plus Analyzer System Dimension QuikLYTE Integrated Multisensor Sample Diluent Dimension QuikLYTE Integrated Multisensor Flush Solution Nova 5 Nova Stat Profile pHOx Plus L Nova Max Link Nova Primary Glucose Analyzer System True Focus Pro Focus Pro Focus

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Manufacture Device in the United States for Export Only Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device