BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HELENA LABORATORIES, CORP.

    Reg #: 1644474 · FEI: 1000116989 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    113
    Establishment Types
    2
    Classifications
    10

    Registration Details

    Registration Name
    HELENA LABORATORIES, CORP.
    Registration Number
    1644474
    FEI Number
    1000116989
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3795 WASHINGTON BLVD.
    City
    BEAUMONT
    State
    TX
    ZIP
    77705
    Country
    US

    Regulatory Submissions

    510(k) Number
    K020914

    Owner / Operator

    Firm Name
    HELENA LABORATORIES, CORP.
    Operator Number
    1618982
    Address
    1530 LINDBERGH DRIVE
    City
    Beaumont
    State
    TX
    Postal Code
    77707
    Country
    US
    Correspondent
    Rachel Easley

    Products

    Device Name Product Code
    Activated Whole Blood Clotting Time JBP
    Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica JQT
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Electrophoretic, Protein Fractionation CEF
    Station, Pipetting And Diluting, For Clinical Use JQW
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Instrument, Coagulation, Automated GKP
    Densitometeric, Protein Fractionation JQJ
    Fluorometric Measurement, Porphyrins JKJ
    Apparatus, Electrophoresis, For Clinical Use JJN

    Proprietary Names

    Actalyke XL Analyzer QuickScan Touch QuickScan 2000 QuickScan Touch PLUS Cascade POC Electronic QC Card Cascade POC Analyzer Cascade EQC Renew Sleeve SPIFE Serum Protein SPIFE 4000 SPIFE 3000 SPIFE Touch QuickGel SPE Vis SPIFE Nexus Amido Black Protein Stain 35uL Micropipette QuickGel Applicator Kit Super Z 12-Applicator Super Z Applicator Kit Super Z Sample Well Plates QuickGel Applicator Base ESH Touch Electrophoresis Sample Handler Super Z-12 Applicator Kit Super Z-12 Sample Well Plates Super Z Applicator QuickGel Applicator Super Z Aligning Base SPIFE 4000 IFE Antisera Pipette Tips Titan Plus Power Supply 10-100 µLVariable Volume Pipette with Tip Ejector H-Pette Remover Zip Zone Applicator QuickGel Modified Applicator Blades Bufferizer Zip Zone Aligning Base Cascade M-4 Cuvettes SPIFE IFE Sample Cups QuickGel Dispo Sample Cups - Shallow Well Zip Zone Prep Actalyke Thermometer SPIFE Urine/CSF Protein Accessories TITAN GEL Chamber Cooling Block SPIFE Dispo Sample Cups - Deep Well SPIFE Urine IFE Accessories SPIFE 4000 IFE Sample Trays REP Prep Solution Pipette Tips 1-200 µL SPIFE IFE-3/6 Urine Accessory Kit SPIFE Applicator Blades SPIFE Modified Applicator Blades Helena Electronic Clotting Tube SPIFE 4000 White Sample Trays SPIFE IFE-6 Rigid Antisera Template Blotter Pads, 76 x 102 mm QuickGel Gel Block Remover SPIFE IFE-3/6 Dispo Cup Tray Blotter Pads, 89 x 108 mm SPIFE Rigid Antisera Template-15 SPIFE Antisera Tray for IFE-6 & IFE-3 Titan Plastic Envelopes, 115 x 102 mm Super Z Micro Replacement Tips Serrated Blade Applicator Kit, 18 Sample (30) Cascade POC Power Supply Serrated Blade Applicator Kit, 20 Sample (10) SPIFE Nexus Applicator Blade Weights SPIFE Nexus Contact Sheets SPIFE Nexus Cassettes SPIFE Nexus Ready Run Kit SPIFE Nexus Carbon Electrode Insert SPIFE Nexus Dispo Stain Cups SPIFE Nexus Antisera Spreader Tips Serrated Blade Applicator Kit, 20 Sample (30) Serrated Blade Applicator Kit, 20 Sample (20) SPIFE Nexus Applicator Templates Serrated Blade Applicator Kit, 12 Sample (30) Serrated Blade Applicator Kit, 20 Sample (50) SPIFE Nexus Reagent Roller Super CK Aligning Base QuickGel IFE Applicator Blades SPIFE 4000 Maintenance Blotters Development Weight QuickGel Applicator Blades Tips for IFE-6/3 Multi-Channel Pipette Blade Applicator Kit, SPIFE 4000 IFE QuickGel Dispo Sample Cups - Deep Well SPIFE Dispo Sample Cups - Shallow Well Tips for IFE-9 Multi-Channel Pipette Titan III Cellulose Acetate Carrying Rack Zip Zone Sample Well Plate Siliconized Cuvettes for AggRAM Tips for IFE-15 Multi-Channel Pipette Electra B1 Buffer 1000 Staining Set Zip Zone Chamber Wicks Actalyke Mini II Analyzer Cascade M Cascade M-4 Optical Density Step Tablet DZA Replacement Lamp for REP Neutral Density Densitometer Control SPIFE 4000 Neutral Density Densitometer Control SPIFE Nexus Neutral Density Densitometer Control for QuickScan Cascade Abrazo Electronic QC Card (EQC) Cascade Abrazo Analyzer AggRAM Analyzer AggRAM Module ProtoFluor Z ProtoFluor Reagent Kit TITAN GEL Isoenzyme Incubation Chamber TITAN GEL Electrophoresis Chamber QuickGel Chamber Titan IV Aligning Base Sponge Wicks

    Establishment Types

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