BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CLINIQA CORPORATION

    Reg #: 2085064 · FEI: 1000135102 · Expires 2026
    View on FDA
    Products
    54
    Proprietary Names
    98
    Establishment Types
    3
    Classifications
    54

    Registration Details

    Registration Name
    CLINIQA CORPORATION
    Registration Number
    2085064
    FEI Number
    1000135102
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    495 Enterprise Street
    City
    San Marcos
    State
    CA
    ZIP
    92078
    Country
    US

    Regulatory Submissions

    510(k) Number
    K041090

    Owner / Operator

    Firm Name
    CLINIQA CORPORATION
    Operator Number
    2083131
    Address
    495 Enterprise Street, --
    City
    San Marcos
    State
    CA
    Postal Code
    92078
    Country
    US
    Correspondent
    Dawn - Gast

    Products

    Device Name Product Code
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
    Prealbumin, Antigen, Antiserum, Control JZJ
    Alkaline Picrate, Colorimetry, Creatinine CGX
    System, Test, C-Reactive Protein DCN
    Calibrator, Secondary JIT
    Brain Trauma Assessment Test QAT
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Acid, Uric, Uricase (Colorimetric) KNK
    Plasma, Coagulation Control GGN
    Colorimetric Method, Gamma-Glutamyl Transpeptidase JPZ
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
    Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
    Apolipoproteins MSJ
    Enzyme Controls (Assayed And Unassayed) JJT
    Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
    Calibrator, Multi-Analyte Mixture JIX
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Catalytic Methods, Amylase JFJ
    Urease, Photometric, Urea Nitrogen CDN
    Urinalysis Controls (Assayed And Unassayed) JJW
    Cresolphthalein Complexone, Calcium CIC
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
    Azo Dye, Calcium CJY
    Test, Time, Prothrombin GJS
    Colorimetry, Cholinesterase DIH
    Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
    Assay, Glycosylated Hemoglobin LCP
    Photometric Method, Magnesium JGJ
    Photometric Method, Iron (Non-Heme) JIY
    Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
    Multi-Analyte Controls Unassayed OHQ
    Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CGS
    System, Test, Low Density, Lipoprotein MRR
    Enzymatic Method, Creatinine JFY
    Albumin, Antigen, Antiserum, Control DCF
    Hexokinase, Glucose CFR
    Calibrator, Primary JIS
    Electrode, Ion Specific, Sodium JGS
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Potassium CEM
    Mercuric Thiocyanate, Colorimetry, Chloride CHJ
    Ldl & Vldl Precipitation, Hdl LBR
    Enzymatic, Carbon-Dioxide KHS
    Lipoprotein, Low-Density, Antigen, Antiserum, Control DFC
    Diazo Colorimetry, Bilirubin CIG
    Alcohol Control Materials DKC
    Antistreptolysin - Titer/Streptolysin O Reagent GTQ
    Haptoglobin, Antigen, Antiserum, Control DAD
    C-Reactive Protein, Antigen, Antiserum, And Control DCK
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
    Kinetic Method, Gamma-Glutamyl Transpeptidase JQB
    Enzymatic Method, Ammonia JIF

    Proprietary Names

    Lipid Calibrator LDL Cholesterol Direct LINICAL PROTEIN 4 CALIBRATIO CREATININE REAGENT CRP REAGENT Cardiac Marker PT PROTEIN 5 CALIBRATION VERIFIERS A-E Uric Acid Reagent Liquid QC® Cardiac Marker Control VS CARDIAC MARKER CONTROL SP 1,2 &3 GGT Reagent GOT (AST) REAGENT LDH-P Reagent APO A-1 Reagent LIQUID QC CARDIAC MARKER CONTROL Phosphorus Reagent Assayed Control Serum Level 2 Assayed Control Serum Level 1 LIQUID QC TDM CONTROL Amylase Reagent LiquidQC™ NEPHROCHECK® Control For VIDAS® 3 NEPHROCHECK® Method Validation For VIDAS® 3 NEPHROCHECK® Calibration Verification For VIDAS® 3 BUN Liquid Reagent LIQUID QC URINALYSIS CONTROLS 1 &2 CALCIUM (OCPC) LIQUID REAGENT CHOLESTEROL RAPID LIQUID REAGENT Triglycerides GPO CALCIUM REAGENT ISTAT PTPLUS CONTROL LEVEL 1; ISTAT PTPLUS CONTROL LEVEL 2 ESOTERICS CALIBRATION VERIFIERS A-E TUMOR MARKER CONTROL 1,2 3 & TRI LIPID CONTROL1& 2;CALIB VERIF A-Z CHOLINESTERASE REAGENT Cholesterol Enzymatic Ethanol/Ammonia control levels 1-3 Alkaline Phosphatase Reagent FRUCTOSAMINE CONTROLS URIC ACID CALIB VERIFIERS A-E HbA1c Reagent and Calibrator CK-MB Reagent Iron TIBC Reagent Cliniqa LIquid QC Unassayed and Ass LiquidQC hsCRP Controls ENZYME CALIB VERIFIERS A-E Liquid QC Unassayed General Chemistry Control DRY QC CHEMISTRY CONTROL PROTEIN 2 CALIBRATION VERIFIERS A-E CK NADP Reagent I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 I-STAT PTPLUS CONTROL LEVEL 1; ISTAT PTPLUS CONTROL LEVEL 2 AMYLASE REAGENT PROTEIN 2 CALIB VERIFIERS LEVEL A-E IMMUNOLOGY CALIBRATION VERIFIER A-E PROTEIN 1 CALIB VERIFIERS A-E HSCRP CALIB VERIFIERS LEVELS A-E CREATININE REAGENT (ENZYMATIC) ImmuTROL LiquidQC Immunology Control Cardiac marker complete DIABETES CONTROL Vitamin D Control CoV-2 IgG Control CoV-2 Ag Control BILIRUBIN CONTROLS1,2 &3;CALB A-Z OLYMPUS URINE CALIBRATOR Glucose UV Reagent BILIRUBIN STANDARD Roche ISE Standard PROTEIN 4 CALIB VERIFIERS LEVEL A-E CHLORIDE REAGENT HDL-Cholesterol Direct CO2 REAGENT APO B Reagent BILIRUBIN REAGENT TOTAL/DIRECT WHOLE BLD VOLATILES CONTROL LEVELS1 AND 2 WHOLE BLOOD ETHANOL CONTROL LEVELS 1 AND 2 LINICAL PROTEIN 3 CALIBRATIO LININCAL PROTEIN 3 CALIBRATI HDL Direct Reagent and Calibrator RF-CRP CALIBRATION VERIFIERS A-E CK NADP Imidazole Reagent BUN RATE REAGENT HCG CONTROL LEVEL 1, 2, AND 3 LIQUID QC URINE CHEM CONTROL 1&2 PROTEIN 3 CALIBRATION VERIFIERS A-E CHEMISTRY CALIBRATION VERIFIERS A-E Cliniqa Beta hCG Calibration Verification Controls Level 1,2&3 Cliniqa Beta hCG Controls Level 1,2&3 LDH-L Reagent ESOTERICS CALIBRATOR VERIFIERS A-Z CRP HIGH SENSITIVITY TEST SYSTEM ALT (GPT) Reagent LIQUIDQC IMMUNOASSAY CONTROL 1,2,3 CO2 XL REAGENT PROTEIN I CALIB VERIFIERS LEVEL A-E AMMONIA REAGENT PROTEIN 3 CALIB VERIFIERS LEVEL A-E

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)