BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Diazyme Laboratories, Inc.

    Reg #: 2032900 · FEI: 3004445302 · Expires 2026
    View on FDA
    Products
    39
    Proprietary Names
    104
    Establishment Types
    3
    Classifications
    39

    Registration Details

    Registration Name
    Diazyme Laboratories, Inc.
    Registration Number
    2032900
    FEI Number
    3004445302
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    12889 GREGG CT
    City
    POWAY
    State
    CA
    ZIP
    92064
    Country
    US

    Regulatory Submissions

    510(k) Number
    K071971

    Owner / Operator

    Firm Name
    Diazyme Laboratories, Inc.
    Operator Number
    9057184
    Address
    12889 Gregg Court, --
    City
    Poway
    State
    CA
    Postal Code
    92064
    Country
    US
    Correspondent
    Abhijit - Datta

    Products

    Device Name Product Code
    Urinary Homocystine (Nonquantitative) Test System LPS
    Calibrator, Multi-Analyte Mixture JIX
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Calibrator, Secondary JIT
    Myoglobin, Antigen, Antiserum, Control DDR
    Assay, Glycosylated Hemoglobin LCP
    Lipoprotein, Low-Density, Antigen, Antiserum, Control DFC
    Test, Cystatin C NDY
    System, Test, Vitamin D MRG
    Retinol-Binding Protein, Antigen, Antiserum, Control CZS
    Apolipoproteins MSJ
    Assay, 1,5-Anhydroglucitol (15ag) NOZ
    5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase CED
    Atomic Absorption, Lithium JII
    Enzyme Controls (Assayed And Unassayed) JJT
    System, Test, Oxalate LPW
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Ldl & Vldl Precipitation, Hdl LBR
    Enzymatic Method, Creatinine JFY
    Test, System, Potassium, Enzymatic Method MZV
    Lipase-Esterase, Enzymatic, Photometric, Lipase CHI
    Kappa, Antigen, Antiserum, Control DFH
    Lambda, Antigen, Antiserum, Control DEH
    Hexokinase, Glucose CFR
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Calprotectin, Fecal NXO
    Fibrin Split Products GHH
    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control DAP
    Enzymatic, Carbon-Dioxide KHS
    Reagent, Coronavirus Serological QKO
    Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission PTF
    Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2 NOE
    C-Reactive Protein, Antigen, Antiserum, And Control DCK
    System, Test, Sodium, Enzymatic Method MZU
    Radioimmunoassay, Cholyglycine, Bile Acids KWW
    Fibrinogen Standard GFX
    Test, Fibrinogen GIS
    Plasma, Fibrinogen Control GIL

    Proprietary Names

    Homocysteine Enzymatic Control Set Diazyme Homocysteine 2 Reagent Enzymatic Assay Homocysteine Enzymatic Assay 5 Point Calibrator Set HDL-LDL Cholesterol Calibrator HDL-Cholesterol Assay Diazyme Myoglobin Assay Diazyme Myoglobin Control Set Diazyme Myoglobin Calibrator Set Glycated Serum Protein Calibrator Set Glycated Serum Protein Assay Glycated Serum Protein Control Set Diazyme Lipoprotein (a) Assay Diazyme Cystatin C Control Set Diazyme Cystatin C Calibrator Set Diazyme Cystatin C Assay Diazyme EZ Vitamin D Assay Diazyme EZ Vitamin D Calibrator Set Diazyme EZ Vitamin D Control Set Homocysteine Enzymatic Assay Auto-dilution Calibrator Homocysteine Enzymatic Assay Diazyme Retinol Binding Protein Assay Calibrator Set Diazyme Retinol Binding Protein Assay Control Set Diazyme Retinol Binding Protein Assay Apolipoprotein A-1 Assay Apolipoprotein A-1/B Calibrator Diazyme 1,5 Anhydroglucitol (1,5, AG) Assay Calibrator Set Diazyme 1,5 Anhydroglucitol (1,5 AG) Control Set Diazyme 1,5 Anhydroglucitol (1,5,AG) Assay 5'-Nucleotidase Control Set 5'-Nucleotidase Calibrator 5'-Nucleotidase Assay Apolipoprotein B Assay Diazyme Liquid Stable Enzymatic Lithium Control Set Diazyme Liquid Stable Enzymatic Lithium Calibrator Set Diazyme Liquid Stable Enzymatic Lithium Assay Homocysteine Control Kit Homocysteine Calibrator Kit Diazyme Oxalate Enzymatic Assay Diazyme b- Hydroxybutyrate (BHB) Calibrator Diazyme b- Hydroxybutyrate (BHB) Controls Diazyme b- Hydroxybutyrate (BHB) Assay Diazyme Direct HbA1c Assay Calibrator Set Diazyme Direct HbA1c Assay Control Set Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis) Diazyme OxLDL Assay Creatinine Liquid Reagent Assay Control Creatinine Liquid Reagent Assay Creatinine Liquid Reagent Assay Calibrator Diazyme Liquid Stable Enzymatic Potassium Calibrator Set Diazyme Liquid Stable Enzymatic Potassium Assay Diazyme Liquid Stable Enzymatic Potassium Control Set Lipase Control Set Lipase Calibrator Lipase Assay Kappa Lambda FLTC Controls REF 06U9510 Lambda FLC Reagent 100T REF 06U9626 Diazyme Human Kappa Free Light Chain Assay Diazyme Human Kappa/Lambda Free Light Chain Control Set Diazyme Human Lambda Free Light Chain Calibrator Set Diazyme Human Kappa Free Light Chain Calibrator Set KFLC Kappa Free Light Chains REF URCI 08896534190 KFLC Kappa Free Light Chains REF URCIII 08896640190 Diazyme Human Lambda Free Light Chain Assay KFLC Kappa Free Light Chains REF URCII 08896542190 Kappa-Lambda FLC Control Set REF 08896577190 LFLC Lambda Free Light Chains REF URCII 08896658190 LFLC Lambda Free Light Chains REF URCI 08896569190 LFLC Lambda Free Light Chains REF URCIII 08896631190 Kappa FLC Reagent 100T REF 06U9525 DzLite c270 LDL-Cholesterol Assay Diazyme Calprotectin Assay Diazyme Calprotectin Control Set Diazyme Calprotectin Calibrator Set Diazyme Lipoprotein (a) Control Set Diazyme Lipoprotein (a) Calibrator Set Diazyme D-Dimer Assay Diazyme D-Dimer Control Set Diazyme D-Dimer Calibrator Set Diazyme Carbon Dioxide Enzymatic Assay Kit Diazyme Carbon Dioxide Enzymatic Diazyme Direct Enzymatic HbA1c Calibrator Set Diazyme Direct Enzymatic HbA1c Control Set Diazyme Direct Enzymatic HbA1c Assay 130219015M Diazyme Dz-Lite SARS-CoV-2 IgG CLIA Kit 130219016M Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit Diazyme Procalcitonin (PCT) Calibrator Set Diazyme Procalcitonin (PCT) Assay Diazyme Procalcitonin (PCT) Control Set PLAC® Test for Lp-PLA2 Activity Diazyme Lp-PLA2 Activity Test Controls Diazyme Lp-PLA2 Activity Test Calibrators Diazyme hsCRP Calibrator Set Diazyme hsCRP Control Set Diazyme hsCRP Assay Diazyme Liquid Stable Enzymatic Sodium Control Set Diazyme Liquid Stable Enzymatic Sodium Calibrator Set Diazyme Liquid Stable Enzymatic Sodium Assay Total Bile Acids Control Set Total Bile Acids Calibrator Total Bile Acids Assay Diazyme Fibrinogen Assay Control Set Diazyme Fibrinogen Assay Calibrator Set Diazyme Fibrinogen Assay

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility