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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Immunoelectrophoretic, Immunoglobulins, (G, A, M) | CFF | Class 2 | Immunology | No | 2008-02-19 |
| Plasma, Coagulation Control | GGN | Class 2 | Hematology | No | 2008-01-28 |
| Control, Plasma, Abnormal | GGC | Class 2 | Hematology | No | 2011-01-17 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 1984-12-31 |
| Test, Time, Prothrombin | GJS | Class 2 | Hematology | No | 2008-04-15 |
| Alpha-1-Antitrypsin Kit, Qualitative Phenotype | OBZ | Class 2 | Immunology | No | 2022-12-15 |
| System, Analysis, Electrophoretic Hemoglobin | JBD | Class 2 | Hematology | No | 2008-01-30 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 1982-12-31 |
| Iga, Fitc, Antigen, Antiserum, Control | CZN | Class 2 | Immunology | No | 2011-01-19 |
| Stain, Ponceau | HZO | Class 1 | Hematology | No | 2008-02-18 |
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2008-01-25 |
| Tube, Collection, Capillary Blood | GIO | Class 1 | Hematology | No | 2013-01-21 |
| Colorimetric Method, Cpk Or Isoenzymes | JHY | Class 2 | Clinical Chemistry | No | 2007-02-15 |
| Stains, Dye Powder | LEF | Class 1 | Hematology | No | 2008-05-06 |
| Reagent, Platelet Aggregation | GHR | Class 2 | Hematology | No | 2008-01-28 |
| Electrophoretic, Protein Fractionation | CEF | Class 1 | Clinical Chemistry | No | 1987-07-23 |
| System, Fibrinogen Determination | KQJ | Class 2 | Hematology | No | 2006-12-12 |
| Test, Qualitative And Quantitative Factor Deficiency | GGP | Class 2 | Hematology | No | 2008-01-23 |
| Plasma, Control, Normal | GIZ | Class 2 | Hematology | No | 2008-04-15 |
| Test, Thrombin Time | GJA | Class 2 | Hematology | No | 2006-12-19 |
| System, Multipurpose For In Vitro Coagulation Studies | JPA | Class 2 | Hematology | No | 2008-01-25 |
| Apparatus, Electrophoresis, For Clinical Use | JJN | Class 1 | Clinical Chemistry | No | 1988-02-19 |
| Gamma Globulin, Antigen, Antiserum, Control | DAH | Class 2 | Immunology | No | 2008-05-06 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2013-01-21 |
| Activated Whole Blood Clotting Time | JBP | Class 2 | Hematology | No | 2008-01-23 |
| Electrophoretic Separation, Lipoproteins | JHO | Class 1 | Clinical Chemistry | No | 2008-01-30 |
| Electrophoretic, Lactate Dehydrogenase Isoenzymes | CFE | Class 2 | Clinical Chemistry | No | 1988-02-19 |
| Test, Time, Partial Thromboplastin | GGW | Class 2 | Hematology | No | 2008-01-28 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2012-10-25 |
| Support Gels | JZR | Class 1 | Immunology | No | 2008-05-06 |
| Abnormal Hemoglobin Quantitation | GKA | Class 2 | Hematology | No | 2008-02-26 |
| Activated Partial Thromboplastin | GFO | Class 2 | Hematology | No | 2015-04-28 |
| Assay, Heparin | KFF | Class 2 | Hematology | No | 2007-12-03 |
| System, Automated Platelet Aggregation | JOZ | Class 2 | Hematology | No | 2008-01-28 |
| Toluidine Blue | IAB | Class 1 | Hematology | No | 2008-05-06 |
| Agent, Clearing | KEM | Class 1 | Pathology | No | 1986-06-25 |
| Fluorometric Measurement, Porphyrins | JKJ | Class 1 | Clinical Chemistry | No | 2007-11-26 |
| Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | CIN | Class 2 | Clinical Chemistry | No | 2008-01-29 |
| Kappa, Antigen, Antiserum, Control | DFH | Class 2 | Immunology | No | 2008-01-30 |
| Lambda, Antigen, Antiserum, Control | DEH | Class 2 | Immunology | No | 2008-01-30 |
| Enzyme Controls (Assayed And Unassayed) | JJT | Class 1 | Clinical Chemistry | No | 2008-02-14 |
| Station, Pipetting And Diluting, For Clinical Use | JQW | Class 1 | Clinical Chemistry | No | 2001-11-09 |
| Pipette, Quantitative, Hematology | GJG | Class 1 | Hematology | No | 2013-01-22 |
| Igd, Antigen, Antiserum, Control | CZJ | Class 2 | Immunology | No | 2008-05-06 |
| Igm, Antigen, Antiserum, Control | DFT | Class 2 | Immunology | No | 2008-05-06 |
| Radioimmunoassay, Immunoglobulins (G, A, M) | CFQ | Class 2 | Immunology | No | 2008-05-06 |
| Aggregrometer, Platelet | JBX | Class 2 | Hematology | No | 2011-01-19 |
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