BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIALEX LAB

    Reg #: 3021841051 · FEI: 3021841051 · Expires 2026
    View on FDA
    Products
    59
    Proprietary Names
    48
    Establishment Types
    2
    Classifications
    59

    Registration Details

    Registration Name
    BIALEX LAB
    Registration Number
    3021841051
    FEI Number
    3021841051
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    717 Ohio Ave
    City
    Wichita Falls
    State
    TX
    ZIP
    76301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K023550

    Owner / Operator

    Firm Name
    Bialex Lab
    Operator Number
    10049801
    Address
    717 Ohio Ave
    City
    Wichita Falls
    State
    TX
    Postal Code
    76301
    Country
    US
    Correspondent
    Carlos H Quine

    Products

    Device Name Product Code
    Radioimmunoassay, Cholyglycine, Bile Acids KWW
    Cresolphthalein Complexone, Calcium CIC
    Acid, Uric, Uricase (Colorimetric) KNK
    Kinetic Method, Gamma-Glutamyl Transpeptidase JQB
    Cardiac C-Reactive Protein, Antigen, Antiserum, And Control NQD
    Biuret (Colorimetric), Total Protein CEK
    Diethyldithiocarbamate (Colorimetric), Copper JKZ
    Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
    System, Test, Low Density, Lipoprotein MRR
    Atp And Creatine Kinase (Enzymatic), Creatine JLB
    Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) NHX
    Photometric Method, Ammonia JID
    Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
    Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase JMK
    Reagents, Test, Tetrahydrocannabinol DKE
    Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
    Colorimetric Method, Triglycerides JGY
    Catalytic Methods, Amylase JFJ
    Immunoassay Method, Troponin Subunit MMI
    Diazo Colorimetry, Bilirubin CIG
    Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes CJH
    System, Test, Rheumatoid Factor DHR
    Lipoprotein, High Density, Hdl, Over The Counter NAQ
    Glucose Oxidase, Glucose CGA
    System, Test, Blood Glucose, Over The Counter NBW
    Ldl & Vldl Precipitation, Hdl LBR
    Test, Triglycerides, Over The Counter NGO
    Ferric Chloride, Phenylketones (Urinary, Non-Quant.) JGK
    Enzymatic Method, Creatinine JFY
    Wet Ash Method, Protein-Bound Iodine JIJ
    Antistreptolysin - Titer/Streptolysin O Reagent GTQ
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    System, Test, Vitamin D MRG
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
    Lipase-Esterase, Enzymatic, Photometric, Lipase CHI
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Test, Amphetamine, Employment And Insurance Testing, Exempt PUX
    Olive Oil Emulsion (Turbidimetric), Lipase CET
    Acid Phosphatase, Naphthyl Phosphate CKB
    System, Test, Sodium, Enzymatic Method MZU
    Calibrator, Secondary JIT
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Nitroprusside Reaction (Qualitative, Urine), Cystine JLC
    Device, Anti-Snoring LRK
    Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry JKL
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Test, System, Potassium, Enzymatic Method MZV
    Nadh, Phosphoglycerate Mutase, Atp (U.V.) 2,3-Diphosphoglyceric Acid JLZ
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
    Ninhydrin, Nitrogen (Amino-Nitrogen) JMX
    Ferrozine (Colorimetric) Iron Binding Capacity JMO
    Bromcresol Purple Dye-Binding, Albumin CJW
    Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase CFH
    Test, Cholesterol, Total, Over The Counter NFX
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Saccharogenic, Amylase CIJ
    Phenylphosphate, Alkaline Phosphatase Or Isoenzymes CKF
    Kit, Identification, Mycobacteria JSY
    Methylthymol Blue, Calcium CIA

    Proprietary Names

    Bialex Uric Acid Bialex GGT Bialex Total Protein Bialex Cu Bialex ALT Bialex LDL Bialex CK Bialex Anti CCP Bialex Ammonia Bialex Phosphorus Bialex ?-HBDH UV Bialex THC Bialex LDH Bialex Triglycerides Bialex Amylase Bialex Dyazo Direct Bilirrubin Bialex Dyazo Total Bilirrubin Bialex Phosphatase Alkaline BIALEX FR Bialex Glucose Oxidase Bialex Ferric Chloride Test System Bialex Creatinine BIALEX ASO Bialex Enzymatic Cholesterol Oxidase Bialex Direct HDL Bialex Precipitation HDL Bialex Emulsion Lipase Bialex Lipase KInetic Bialex Albumin Bromcresol Bialex Amphetamine Bialex Kinetic Lipase Bialex Acid phosphatase prostatic Bialex Na Bialex Cystine ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE Bialex Easy Lead-Check Bialex PassCheck Multicontrol Bialex PassCheck Calibrator Bialex K Bialex LDL Precipitant Bialex Easy Hemo-Oxy Bialex AST BIALEX NITROGEN TEST SYSTEM Bialex Ferrozine Bialex COC BIALEX AST BIALEX AMYLASE Bialex I-Mycobacteria Test

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device