BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STANBIO LABORATORY

    Reg #: 1616487 · FEI: 1616487 · Expires 2026
    View on FDA
    Products
    83
    Proprietary Names
    0
    Establishment Types
    5
    Classifications
    83

    Registration Details

    Registration Name
    STANBIO LABORATORY
    Registration Number
    1616487
    FEI Number
    1616487
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1261 NORTH MAIN ST.
    City
    Boerne
    State
    TX
    ZIP
    78006
    Country
    US

    Regulatory Submissions

    510(k) Number
    K871456

    Owner / Operator

    Firm Name
    STANBIO LABORATORY
    Operator Number
    1616487
    Address
    1261 NORTH MAIN ST., --
    City
    Boerne
    State
    TX
    Postal Code
    78006
    Country
    US

    Products

    Device Name Product Code
    Hexokinase, Glucose CFR
    Instrument, Hematocrit, Automated GKF
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Assay, Glycosylated Hemoglobin LCP
    System, Hemoglobin, Automated GKR
    Albumin, Antigen, Antiserum, Control DCF
    Centrifuge, Hematocrit GKG
    Colorimetry, Acetaminophen LDP
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Catalytic Methods, Amylase JFJ
    Drug Mixture Control Materials DIF
    U.V. Method, Cpk Isoenzymes JHW
    Antistreptolysin - Titer/Streptolysin O Reagent GTQ
    Mixture, Hematology Quality Control JPK
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Calibrators, Drug Mixture DKB
    Cresolphthalein Complexone, Calcium CIC
    Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls LJM
    System, Test, C-Reactive Protein DCN
    Diazo Colorimetry, Bilirubin CIG
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Calibrator, Multi-Analyte Mixture JIX
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion Specific, Potassium CEM
    Antigens, All Groups, Streptococcus Spp. GTY
    Enzymatic Method, Creatinine JFY
    Mercuric Thiocyanate, Colorimetry, Chloride CHJ
    Culture Media, Non-Selective And Non-Differential JSG
    Helicobacter Pylori LYR
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Enzymatic Method, Bilirubin JFM
    Whole Blood Hemoglobin Determination KHG
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Calibrator, Secondary JIT
    Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ
    Kinetic Method, Gamma-Glutamyl Transpeptidase JQB
    Photometric Method, Iron (Non-Heme) JIY
    System, Test, Infectious Mononucleosis KTN
    Alkaline Picrate, Colorimetry, Creatinine CGX
    Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CGS
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Test, Urine Leukocyte LJX
    Automated Urinalysis System KQO
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Refractometer For Clinical Use JRE
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Blood, Occult, Colorimetric, In Urine JIO
    Biuret (Colorimetric), Total Protein CEK
    Acid, Uric, Uricase (Colorimetric) KNK
    Azo Dye, Calcium CJY
    Colorimetry, Salicylate DKJ
    Control, Hemoglobin GGM
    Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
    Urinalysis Controls (Assayed And Unassayed) JJW
    Glucose Oxidase, Glucose CGA
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
    Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
    Visual, Pregnancy Hcg, Prescription Use JHI
    Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) JMA
    Tube, Collection, Capillary Blood GIO
    Ldl & Vldl Precipitation, Hdl LBR
    Reagent, Occult Blood KHE
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
    Control, Hematocrit GLK
    Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
    Microbial Nucleic Acid Storage And Stabilization Device QBD
    Antigens, Nontreponemal, All GMQ
    System, Test, Low Density, Lipoprotein MRR
    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
    Cytocentrifuge IFB
    Photometric Method, Magnesium JGJ
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
    Enzymatic, Carbon-Dioxide KHS
    System, Test, Rheumatoid Factor DHR
    System, Test, Blood Glucose, Over The Counter NBW
    Glucose Dehydrogenase, Glucose LFR
    Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission PTF
    Colorimetric Method, Triglycerides JGY

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only