BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SPIFE Urine IFE Accessories

    Reg #: 1618982 · FEI: 1618982 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    67
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HELENA LABORATORIES, CORP.
    Registration Number
    1618982
    FEI Number
    1618982
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1530 Lindbergh Dr
    City
    BEAUMONT
    State
    TX
    ZIP
    77707
    Country
    US

    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
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG

    Proprietary Names

    SPIFE Urine IFE Accessories Titan III Cellulose Acetate Carrying Rack SPIFE 4000 IFE Antisera Pipette Tips Zip Zone Applicator Actalyke Thermometer H-Pette Remover REP Prep Solution SPIFE Urine/CSF Protein Accessories QuickGel IFE Applicator Blades Tips for IFE-15 Multi-Channel Pipette Electra B1 Buffer 1000 Staining Set Zip Zone Sample Well Plate SPIFE Dispo Sample Cups - Deep Well QuickGel Dispo Sample Cups - Shallow Well Pipette Tips 1-200 µL SPIFE 4000 White Sample Trays SPIFE Modified Applicator Blades Helena Electronic Clotting Tube SPIFE Applicator Blades SPIFE IFE-3/6 Urine Accessory Kit Blotter Pads, 76 x 102 mm Titan Plastic Envelopes, 115 x 102 mm Super Z Micro Replacement Tips Blotter Pads, 89 x 108 mm SPIFE Antisera Tray for IFE-6 & IFE-3 SPIFE Rigid Antisera Template-15 QuickGel Gel Block Remover SPIFE IFE-6 Rigid Antisera Template SPIFE IFE-3/6 Dispo Cup Tray Cascade POC Power Supply SPIFE Nexus Carbon Electrode Insert SPIFE Nexus Cassettes Serrated Blade Applicator Kit, 20 Sample (30) Serrated Blade Applicator Kit, 20 Sample (10) Serrated Blade Applicator Kit, 20 Sample (50) SPIFE Nexus Dispo Stain Cups SPIFE Nexus Reagent Roller SPIFE Nexus Contact Sheets Serrated Blade Applicator Kit, 12 Sample (30) SPIFE Nexus Applicator Blade Weights SPIFE Nexus Ready Run Kit Serrated Blade Applicator Kit, 18 Sample (30) SPIFE Nexus Applicator Templates Serrated Blade Applicator Kit, 20 Sample (20) SPIFE Nexus Antisera Spreader Tips Titan Plus Power Supply SPIFE 4000 Maintenance Blotters Bufferizer Zip Zone Aligning Base SPIFE 4000 IFE Sample Trays Blade Applicator Kit, SPIFE 4000 IFE QuickGel Dispo Sample Cups - Deep Well 10-100 µLVariable Volume Pipette with Tip Ejector TITAN GEL Chamber Cooling Block Super CK Aligning Base Cascade M-4 Cuvettes QuickGel Applicator Blades SPIFE Dispo Sample Cups - Shallow Well Zip Zone Chamber Wicks Tips for IFE-9 Multi-Channel Pipette Development Weight Tips for IFE-6/3 Multi-Channel Pipette SPIFE IFE Sample Cups Zip Zone Prep Siliconized Cuvettes for AggRAM QuickGel Modified Applicator Blades

    Establishment Types

    Manufacture Medical Device