BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MEDICA CORP.

    Reg #: 1220972 · FEI: 1220972 · Expires 2026
    View on FDA
    Products
    56
    Proprietary Names
    49
    Establishment Types
    2
    Classifications
    56

    Registration Details

    Registration Name
    MEDICA CORP.
    Registration Number
    1220972
    FEI Number
    1220972
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5 OAK PARK DRIVE
    City
    BEDFORD
    State
    MA
    ZIP
    01730
    Country
    US

    Regulatory Submissions

    510(k) Number
    K032764

    Owner / Operator

    Firm Name
    MEDICA CORP.
    Operator Number
    1220972
    Address
    5 OAK PARK DRIVE, --
    City
    Bedford
    State
    MA
    Postal Code
    01730
    Country
    US
    Correspondent
    Photios E Makris

    Products

    Device Name Product Code
    Enzyme Immunoassay, Barbiturate DIS
    Drug Specific Control Materials LAS
    Calibrators, Drug Specific DLJ
    Electrode, Ion Specific, Potassium CEM
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion-Specific, Chloride CGZ
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Calibrator, Secondary JIT
    Glucose Oxidase, Glucose CGA
    Flame Photometry, Lithium JIH
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Photometric Method, Magnesium JGJ
    Photometric Method, Iron (Non-Heme) JIY
    Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
    Diazo Colorimetry, Bilirubin CIG
    Calibrator, Multi-Analyte Mixture JIX
    Electrolyte Controls (Assayed And Unassayed) JJR
    Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method DIC
    Enzyme Immunoassay, Opiates DJG
    Wire, Fixation, Intraosseous DZK
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Phencyclidine LCM
    Acid, Uric, Uricase (Colorimetric) KNK
    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
    Hexokinase, Glucose CFR
    Catalytic Methods, Amylase JFJ
    Electrode, Ion Specific, Calcium JFP
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Colorimetric Method, Gamma-Glutamyl Transpeptidase JPZ
    Biuret (Colorimetric), Total Protein CEK
    Enzyme Immunoassay, Benzodiazepine JXM
    Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
    Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CGS
    Alkaline Picrate, Colorimetry, Creatinine CGX
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Azo Dye, Calcium CJY
    Enzyme Immunoassay, Cannabinoids LDJ
    Lipase-Esterase, Enzymatic, Photometric, Lipase CHI
    Instrument, Hematocrit, Automated GKF
    Enzymatic Method, Creatinine JFY
    Enzymatic, Carbon-Dioxide KHS
    Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
    Bromcresol Green Dye-Binding, Albumin CIX
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Colorimetric Method, Cpk Or Isoenzymes JHY
    C-Reactive Protein, Antigen, Antiserum, And Control DCK
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
    Albumin, Antigen, Antiserum, Control DCF
    Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
    Enzyme Immunoassay, Propoxyphene JXN
    Kinetic Method, Gamma-Glutamyl Transpeptidase JQB
    System, Test, Low Density, Lipoprotein MRR
    Assay, Glycosylated Hemoglobin LCP
    Enzyme Immunoassay, Methadone DJR

    Proprietary Names

    Barbiturates (BAR) EasyRA TBIL,DBIL,FE,PHOS,MG EasyRA Reag EasyCAL & EasyQC for EasyRA EasyLyte Na/K EtOH urine, EasyRA assay Amphetamines (AMP) EasyLyte Lithium EasyElectroLytes Na/K/Li RapidChem Na/K/Li AMY,BUN,TRIG,URIC,GLU-H EasyRA Reag EasyLyte Ca/Cl Oxycodone (OXY) GAMMA-GLUTAMYL TRANSFERASE (GGT) Reagent Total Protein (TP) Assay BZO Lactate Dehydrogenase (LDH) Assay EasyRA Creatinine Kinase (CK) Reagent EasyRA Total Bilirubin (TBIL) Reagent EasyRA Direct Bilirubin (DBIL) Reagent Capillary Adaptor Accessory EasyRA Creatinine (CREA) Reagent Cholesterol and Calcium EasyRA reag THC EasyLyte Na/K/Cl/Li EasyRA Lipase Reagent RapidPoint 350 EASYSTAT ALB,ALP,AST,CO2,CREA,CK EasyRA Reag EasyLyte Na/K/Ca/pH CK-MB EasyRA Reagent HDL EasyRA Reagent & Calibrator CREA-U Reagent micro-albumin in urine, EasyRA assay EasyBloodGas RapidPoint 340 Alanine aminotransferase(ALT) Assay PPX urine, EasyRA assay Gamma-Glutamyl Transferase (GGT) Assay EasyStat Buprenorphine (BUN) EasyLyte Plus LDL direct, EasyRA assay EasyRA HbA1c Reagent, Calibrators & controls EasyElectroLytes Na/K/Cl RapidChem Na/K/Cl OXY EasyLyte EXPAND MTD

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device