HELENA LABORATORIES, CORP.

FDA Device Registration & Listing · BEAUMONT, TX, US · Registration 1618982

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1618982
FEI Number
1618982
Entity Name
HELENA LABORATORIES, CORP.
City/State/Country
BEAUMONT, TX, US
Establishment Address
1530 Lindbergh Dr, BEAUMONT, TX 77707, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
HELENA LABORATORIES, CORP. (Owner Number: 1618982)
Owner / Operator Contact Address
1530 LINDBERGH DRIVE, Beaumont, TX 77707, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M) Immunology Class 2 866.5510 2008-02-19
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2008-01-28
GGC Control, Plasma, Abnormal Hematology Class 2 864.5425 2011-01-17
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 1984-12-31
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2008-04-15
GJS Test, Time, Prothrombin Hematology Class 2 864.7750 2008-04-15
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-12-15
OBZ Alpha-1-Antitrypsin Kit, Qualitative Phenotype Immunology Class 2 866.5130 2022-12-15
JBD System, Analysis, Electrophoretic Hemoglobin Hematology Class 2 864.7440 2008-01-30
CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M) Immunology Class 2 866.5510 2008-02-19
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 1982-12-31
CZN Iga, Fitc, Antigen, Antiserum, Control Immunology Class 2 866.5510 2011-01-19
HZO Stain, Ponceau Hematology Class 1 864.1850 2008-02-18
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2008-01-25
GIO Tube, Collection, Capillary Blood Hematology Class 1 864.6150 2013-01-21
JHY Colorimetric Method, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2007-02-15
LEF Stains, Dye Powder Hematology Class 1 864.1850 2008-05-06
GHR Reagent, Platelet Aggregation Hematology Class 2 864.5700 2008-01-28
CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M) Immunology Class 2 866.5510 2008-02-19
CEF Electrophoretic, Protein Fractionation Clinical Chemistry Class 1 862.1630 1987-07-23
KQJ System, Fibrinogen Determination Hematology Class 2 864.7340 2006-12-12
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2008-01-23
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2008-05-08
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2013-01-21
GIZ Plasma, Control, Normal Hematology Class 2 864.5425 2008-04-15
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-04-15
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2008-04-15
GGC Control, Plasma, Abnormal Hematology Class 2 864.5425 2008-04-15
GJA Test, Thrombin Time Hematology Class 2 864.7875 2006-12-19
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2008-04-15
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2008-01-25
GHR Reagent, Platelet Aggregation Hematology Class 2 864.5700 2008-01-28
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2011-01-20
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2008-01-28
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2008-03-07
JJN Apparatus, Electrophoresis, For Clinical Use Clinical Chemistry Class 1 862.2485 1988-02-19
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2008-01-23
DAH Gamma Globulin, Antigen, Antiserum, Control Immunology Class 2 866.5510 2008-05-06
JBD System, Analysis, Electrophoretic Hemoglobin Hematology Class 2 864.7440 2008-01-28
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2000-04-07
CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M) Immunology Class 2 866.5510 2008-02-19
JRC Micro Pipette Clinical Chemistry Class 1 862.2050 2013-01-21
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2008-01-23
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 1982-12-31
CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M) Immunology Class 2 866.5510 2008-02-19
CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M) Immunology Class 2 866.5510 2008-02-19
JBP Activated Whole Blood Clotting Time Hematology Class 2 864.7140 2008-01-23
GHR Reagent, Platelet Aggregation Hematology Class 2 864.5700 1983-12-31
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2008-01-23
JBD System, Analysis, Electrophoretic Hemoglobin Hematology Class 2 864.7440 2008-01-28
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2011-01-24
CEF Electrophoretic, Protein Fractionation Clinical Chemistry Class 1 862.1630 1987-07-23
CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M) Immunology Class 2 866.5510 2008-02-19
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2008-01-23
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-01-29
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2008-02-07
JHO Electrophoretic Separation, Lipoproteins Clinical Chemistry Class 1 862.1475 2008-01-30
CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M) Immunology Class 2 866.5510 2008-02-19
JBD System, Analysis, Electrophoretic Hemoglobin Hematology Class 2 864.7440 2008-01-28
CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes Clinical Chemistry Class 2 862.1445 1988-02-19
GGW Test, Time, Partial Thromboplastin Hematology Class 2 864.7925 2008-01-28
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2008-01-22
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2008-01-23
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2012-10-25
JZR Support Gels Immunology Class 1 866.4900 2008-05-06
GIZ Plasma, Control, Normal Hematology Class 2 864.5425 2014-06-02
GKA Abnormal Hemoglobin Quantitation Hematology Class 2 864.7415 2008-02-26
GHR Reagent, Platelet Aggregation Hematology Class 2 864.5700 2008-01-28
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2013-12-23
GJS Test, Time, Prothrombin Hematology Class 2 864.7750 2011-01-19
GFO Activated Partial Thromboplastin Hematology Class 2 864.7925 2015-04-28
KFF Assay, Heparin Hematology Class 2 864.7525 2007-12-03
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2007-11-28
JBP Activated Whole Blood Clotting Time Hematology Class 2 864.7140 2007-11-19
GIZ Plasma, Control, Normal Hematology Class 2 864.5425 2008-01-23
JOZ System, Automated Platelet Aggregation Hematology Class 2 864.5700 2008-01-28
GFO Activated Partial Thromboplastin Hematology Class 2 864.7925 2008-04-15
CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M) Immunology Class 2 866.5510 2008-02-19
CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M) Immunology Class 2 866.5510 2008-02-19
IAB Toluidine Blue Hematology Class 1 864.1850 2008-05-06
KEM Agent, Clearing Pathology Class 1 864.4010 1986-06-25
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2011-01-19
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2008-01-25
GFO Activated Partial Thromboplastin Hematology Class 2 864.7925 1983-12-31
JOZ System, Automated Platelet Aggregation Hematology Class 2 864.5700 2007-02-15
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2011-01-24
JKJ Fluorometric Measurement, Porphyrins Clinical Chemistry Class 1 862.1595 2007-11-26
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2008-02-07
CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes Clinical Chemistry Class 2 862.1050 2008-01-29
GKA Abnormal Hemoglobin Quantitation Hematology Class 2 864.7415 2022-07-15
JBD System, Analysis, Electrophoretic Hemoglobin Hematology Class 2 864.7440 2022-07-15
JBD System, Analysis, Electrophoretic Hemoglobin Hematology Class 2 864.7440 2008-01-28
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2008-01-23
GHR Reagent, Platelet Aggregation Hematology Class 2 864.5700 2008-01-24
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2018-02-28
JBP Activated Whole Blood Clotting Time Hematology Class 2 864.7140 2016-01-20
CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M) Immunology Class 2 866.5510 1987-07-23
KFF Assay, Heparin Hematology Class 2 864.7525 2014-05-28
JHO Electrophoretic Separation, Lipoproteins Clinical Chemistry Class 1 862.1475 1987-07-23
CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M) Immunology Class 2 866.5510 2008-01-30
JBD System, Analysis, Electrophoretic Hemoglobin Hematology Class 2 864.7440 2008-01-30
CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes Clinical Chemistry Class 2 862.1050 1988-02-19
CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M) Immunology Class 2 866.5510 2008-01-30
DFH Kappa, Antigen, Antiserum, Control Immunology Class 2 866.5550 2008-01-30
DEH Lambda, Antigen, Antiserum, Control Immunology Class 2 866.5550 2008-01-30

Official Correspondent

Rachel Easley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HELENA LABORATORIES, CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2916657 LABCON, NORTH AMERICA PETALUMA, CA, US
1644474 HELENA LABORATORIES, CORP. BEAUMONT, TX, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K021022 Instrumentation Laboratory CO HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) 2002-05-14
K113211 Instrumentation Laboratory CO HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL 2012-01-04
K082859 Instrumentation Laboratory CO HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED 2008-12-19
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0514-2014 Instrumentation Laboratory Co. 2
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Z-0515-2014 Instrumentation Laboratory Co. 2
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Z-0516-2014 Instrumentation Laboratory Co. 2
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0077-2019 Instrumentation Laboratory Co. 2
Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1618982. Last updated year: 2026. Please use registration number 1618982 when referencing this establishment in official correspondence.
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