FDA Registration Active 🇺🇸 United States

HELENA LABORATORIES, CORP.

Reg #: 1618982 · FEI: 1618982 · Expires 2026
Products
47
Proprietary Names
304
Establishment Types
4
Classifications
47

Registration Details

Registration Name
HELENA LABORATORIES, CORP.
Registration Number
1618982
FEI Number
1618982
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
1530 Lindbergh Dr
City
BEAUMONT
State
TX
ZIP
77707
Country
US

Regulatory Submissions

510(k) Number
K905673

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
Immunoelectrophoretic, Immunoglobulins, (G, A, M) CFF
Plasma, Coagulation Control GGN
Control, Plasma, Abnormal GGC
Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
Test, Time, Prothrombin GJS
Alpha-1-Antitrypsin Kit, Qualitative Phenotype OBZ
System, Analysis, Electrophoretic Hemoglobin JBD
Multi-Analyte Controls, All Kinds (Assayed) JJY
Iga, Fitc, Antigen, Antiserum, Control CZN
Stain, Ponceau HZO
Reagent, Occult Blood KHE
Tube, Collection, Capillary Blood GIO
Colorimetric Method, Cpk Or Isoenzymes JHY
Stains, Dye Powder LEF
Reagent, Platelet Aggregation GHR
Electrophoretic, Protein Fractionation CEF
System, Fibrinogen Determination KQJ
Test, Qualitative And Quantitative Factor Deficiency GGP
Plasma, Control, Normal GIZ
Test, Thrombin Time GJA
System, Multipurpose For In Vitro Coagulation Studies JPA
Apparatus, Electrophoresis, For Clinical Use JJN
Gamma Globulin, Antigen, Antiserum, Control DAH
Micro Pipette JRC
Activated Whole Blood Clotting Time JBP
Electrophoretic Separation, Lipoproteins JHO
Electrophoretic, Lactate Dehydrogenase Isoenzymes CFE
Test, Time, Partial Thromboplastin GGW
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
Support Gels JZR
Abnormal Hemoglobin Quantitation GKA
Activated Partial Thromboplastin GFO
Assay, Heparin KFF
System, Automated Platelet Aggregation JOZ
Toluidine Blue IAB
Agent, Clearing KEM
Fluorometric Measurement, Porphyrins JKJ
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes CIN
Kappa, Antigen, Antiserum, Control DFH
Lambda, Antigen, Antiserum, Control DEH
Enzyme Controls (Assayed And Unassayed) JJT
Station, Pipetting And Diluting, For Clinical Use JQW
Pipette, Quantitative, Hematology GJG
Igd, Antigen, Antiserum, Control CZJ
Igm, Antigen, Antiserum, Control DFT
Radioimmunoassay, Immunoglobulins (G, A, M) CFQ
Aggregrometer, Platelet JBX

Proprietary Names

Trivalent Antiserum AbTrol 3 Coagulation Control Specialty Assayed Control-2 Gel Alk. Phosphatase IsoenzymeContr Cascade POC PT-WB Level 2 Control Cascade POC PT-WB Test Controls Cascade POC PT-WB Level 1 Control SPIFE A1AT Kit SPIFE A1AT Controls SPIFE Acid Hemoglobin QuickGel Acid Hemoglobin Kit SPIFE 4000 Acid Hemoglobin Kit SPIFE Nexus Acid Hemoglobin SPIFE/QuickGel Acid Hemoglobin Kit IEP Normal Human Serum Control SPE Normal Control Titan Gel IFE Antisera to Free Lambda Light Titan Gel IFE Antisera to Free Kappa Light TITAN GEL IFE Free Lambda & Kappa Antiserum Ponceau S Stain ColoCARE Screening Pack ColoCARE Cascade PT-WB Dispo Capillary Pipette SPIFE/QuickGel CK Kits SPIFE CK Kit QuickGel CK Kit 0-Dianisidine Stain Collagen Reagent Albumin Marker SPIFE SPE Hi Res-20 Kit Titan III Zip Zone Cellulose Acetate Titan III Cellulose Acetate SPIFE 4000 Split Beta SPE TITAN Gel Serum Protein Kit TITAN Gel High Resolution Protein Kit V8 Serum Protein Buffer V8 Maintenance Buffer Kit SPIFE Nexus Split Beta SPE-20, 40, 60 Kit V8 Serum Protein SPE Kit V8 Storage Buffer Kit V8 Urine Preparation Buffer Kit SPIFE Nexus Split Beta SPE - 80, 100 Kit QuickGel Split Beta SPE Kit SPIFE Split Beta SPE Kit FIBRINOGEN KIT Factor XI Def. Substrate Plasma Rocket Stain (Coomassie Blue) von Willebrand Factor Antigen ELISA Kit Cascade POC c-ACT Level 2 Control Cascade POC c-ACT Level 1 Control Cascade POC c-ACT Test Controls THROMBIN CLOTTING TIME REAGENT Cascade POC aPTT Test Controls Cascade POC aPTT Level 1 Control Cascade POC aPTT Level 2 Control Owren's Veronal Buffer Epinephrine SPE Control Norm-Trol Factor VIII Related Antigen EIA TITAN GEL Isoenzyme Incubation Chamber TITAN GEL Electrophoresis Chamber QuickGel Chamber Titan IV Aligning Base Sponge Wicks Factor IX Deficient Substrate Plasm TITAN GEL IFE Plus Kit AFSC Hemoglobin Control ColoScreen Tape ColoScreen Antiserum to Human IgG SPIFE IFE Multi-Channel Pipette Factor VIII Def. Substrate Plasma SPE Control -Abnormal Pentavalent Antiserum to Human Immu Antiserum to Human IgA C-ACT, G-ACT, K-ACT Tubes Platelet Aggregation Kit Factor X Def. Substrate Plasma AA2 Hemoglobin Control LipoTrol SPIFE Serum Protein SPIFE 4000 SPIFE 3000 SPIFE Touch QuickGel SPE Vis SPIFE Nexus Amido Black Protein Stain Antiserum to Human IgE Factor VII Def. Substrate Plasma Alk. Phosphatase Isoenzyme Control Protein S ELISA Kit QuickGel Cholesterol Kit SPIFE/QuickGel Cholesterol Kits-Mul SPIFE Cholesterol Profile Antiserum to Human Serum AFSA2 Hemo Control SPIFE/QuickGel LD Isoenzyme Kits SPIFE LD Isoenzyme Kit QuickGel LD Isoenzyme Kit AbTrol 2 Coagulation Control Ristocetin Cofactor Factor II Def. Substrate Plasma 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 TITAN GEL IEP Stain TITAN GEL IEPlate IEP Sponge Wicks Double Diffusion Plates Cascade Abrazo c-ACT Level 1 Control Hemolysate Reagent Hemolysate Reagent (Powder) Hemolysate Reagent without KCN ADP Reagent V8 SP Normal Control V8 SP Abnormal Control Thromboplastin-LI Reagent Cascade Abrazo aPTT Assay Cascade POC c-ACT Actalyke QC Kit - AQC-HP Actalyke QC Kits Actalyke QC Kit - AQC-LP MAX-ACT Tubes Specialty Assayed Control-1 Ristocetin 15 mg/ml Cascade POC aPTT Test Antiserum to Human IgM Antiserum to Human IgD 0-Tolidine Clear Aid PermaClear Clearing Solution Hi Res Marker ColoScreen-ES APTT-SA Reagent Calcium Chloride Plateletworks ADP Kit Plateletworks Combo-15 Kit Plateletworks Collagen Kit PLATELETWORKS SYSTEM-MULTIPLE Plateletworks Combo-10 Kit Plateletworks Combo-25 Kit Specialty Assayed Reference Plasma (SARP) ProtoFluor Z ProtoFluor Reagent Kit Protein C ELISA Kit TITAN GEL Alk. Phosphatase Kit V8 Nexus Hemoglobin Ultrascreen V8 AFSA2 Hemo Control ASA2 Hemoglobin Control Factor XII Def. Substrate Plasma Plateletworks Arachidonic Acid ColoScreen iFOBT Cascade Abrazo c-ACT-LR Test Card SPIFE IgG IEF Kit SPIFE IgG IEF Kits Cascade Abrazo c-ACT Assay SPIFE/QuickGel Lipoprotein Kits Mul QuickGel Lipoprotein Kit SPIFE Lipoprotein Kit SPIFE 4000 IFE SPIFE Nexus IFE-15 Kit SPIFE Nexus IFE-9 Kit SPIFE Nexus IFE-6 Kit SPIFE/QuickGel IFE Kits-Multiple SPIFE IFE SPIFE IFE-15 QuickGel IFE SPIFE Ultra IFE-15 SPIFE Ultra IFE SPIFE Alkaline Hemoglobin QuickGel Alkaline Hemoglobin Kit SPIFE Nexus Alkaline Hemoglobin SPIFE/QuickGel Alk. Hemoglobin Kit SPIFE ALP Separation Enhancer SPIFE Alk. Phosphatase Kit SPIFE IFE Pentavalent Kits CK/LD Control Antiserum to Human Kappa Light Chai Cascade POC PT-C Level 2 Control Cascade POC PT-C Level 1 Control Cascade POC PT-C Test Controls Scale Set Solutions 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 H-Pette H-Pette with Blade H-Pette II H-Pette without Blade C-Pette Lipoprotein Stain Coolant Sponges Titan III Lipo IFE Antisera to IgE TITAN GEL IFE D & E Antiserum IFE Antisera to IgD Cascade Abrazo PT-C Level 2 Control Cascade Abrazo PT-C Level 1 Control Cascade Abrazo PT-WB Level 1 Control Cascade Abrazo c-ACT-LR Level 2 Control Cascade Abrazo aPTT Level 1 Control Cascade Abrazo PT-WB Level 2 Control Cascade Abrazo c-ACT-LR Level 1 Control Cascade Abrazo aPTT Level 2 Control Titan Gel ImmunoFix Kit Cascade Abrazo Electronic QC Card (EQC) Cascade Abrazo Analyzer Factor V Def. Substrate Plasma Antiserum to Human Lambda Light Cha Titan III-H Cellulose Acetate Plate Supre-Heme Buffer Titan IV Citrate Agar Electra HR Buffer Titan IV IEPlate Citrate Buffer TITAN GEL IFE Controls Cascade Abrazo c-ACT Level 2 Control Cascade Abrazo PT-WB Assay Cascade Abrazo PT-C Assay Free Protein S Reagent V8 AA2 Elevated Hemo Control V8 AA2 Normal Hemo Control Cascade POC PT-WB Test Monoclonal Free Protein S ELISA Alk. Phosphatase Indolyl Blue Cascade POC PT-C TITAN GEL IFE Trivalent Cholesterol Profile Control Arachidonic Acid

Establishment Types

Manufacture Medical Device Manufacture Device in the United States for Export Only Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility