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Helena Laboratories, Corp.

Last updated September 17, 2026

About

Helena Laboratories provides quality products and services to customers worldwide. Our products include electrophoresis analyzers and supplies, densitometers, hemostasis reagents and instruments, immunology and protein diagnostic systems, disposable laboratory plasticware, fecal occult blood test kits, and a wide range of additional laboratory solutions.

From the manufacturer's own website. Source

Information

Country: US
Address: 1530 Lindbergh Dr, BEAUMONT, TX, 77707
Website: www.helena.com
LinkedIn: linkedin.com/company/helena-laboratories-corporation
Facebook: facebook.com/HelenaLaboratories
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1618982
DUNS Number: —

Catalogue (662)

Page 1 of 14

Device	Model / Reference	Registries	Class	Status
TITAN GEL Serum Protein Kit	3041	FDA UDI	Class I	Active
Ristocetin Cofactor Assay Kit	5370	FDA UDI	Class II	Active
Platelet Aggregation Kit	5369	FDA UDI	Class II	Active
Factor XII Deficient Substrate Plasma	5197	FDA UDI	Class II	Active
SPIFE ImmunoFix-3/6 Applicator Kit	551716	FDA UDI	Class II	Active
ColoCARE Screening Pack	5650	FDA UDI	Class II	Active
Blade Applicator Kit, Modified-20 Sample (30)	552001	FDA UDI	Class I	Active
Super Z Applicator (8-sample)	4084	FDA UDI	Class I	Active
Pipette, Variable Volume, 10-100 microliter	6300000	FDA UDI	Class I	Active
Abnormal HbA2 Quik Column Control	5333	FDA UDI	Class II	Unknown
Blade Applicator Kit, Modified-20 Sample (10)	551999	FDA UDI	Class I	Active
Plateletworks Arachidonic Acid Kit	5864	FDA UDI	Class II	Active
ColoScreen Developer 2	5078	FDA UDI	Class II	Active
ColoScreen-ES Developer-15	5088	FDA UDI	Class II	Active
ProtoFluor Z (220V)	2006000	FDA UDI	Class I	Active
Optical Density Step Tablet (10-step)	1047000	FDA UDI	Class I	Active
LipoTrol (5 x 1 mL)	5069	FDA UDI	Class I	Active
ProtoFluor Reagent System (Part 2 of 2)	551057	FDA UDI	Class I	Active
ColoScreen iFOBT Mailer	5063	FDA UDI	Class II	Active
ColoScreen Lab Pack	5072	FDA UDI	Class II	Active
V8 Maintenance Buffer Kit	1832	FDA UDI	Class I	Active
Super Z Applicator Kit (8-sample)	4088	FDA UDI	Class I	Active
Antiserum to Human Kappa Light Chain	9262	FDA UDI	Class II	Active
ColoScreen iFOBT Office Kit	5064	FDA UDI	Class II	Active
SPIFE IFE-9/15 Disposable Sample Cups	3363	FDA UDI	Class I	Active
SPIFE ImmunoFix-9 Antisera Kit	551841	FDA UDI	Class II	Active
Zip Zone Prep (1 x 60 mL)	5090	FDA UDI	Class I	Active
Tips for IFE-15 Multi-Channel Pipette (4 x 204)	3355	FDA UDI	Class I	Active
Hemolysate Reagent	5127	FDA UDI	Class II	Active
SPIFE SPE Gel Kit	552577	FDA UDI	Class I	Active
QuickGel CK Vis Gel Kit	552396	FDA UDI	Class II	Active
K-ACT Tubes	K-ACT	FDA UDI	Class II	Active
Thromboplastin-LI Reagent Kit	5248	FDA UDI	Class II	Active
Tris-Buffered Saline	5365	FDA UDI	Class II	Active
SPIFE Nexus IFE-6 Antisera Kit	552737	FDA UDI	Class II	Active
Blade Applicator Kit, 20 Sample	551765	FDA UDI	Class II	Active
Antiserum to Human Immunoglobulins Trivalent (G, A, M)	9236	FDA UDI	Class II	Active
Tris-Tricine Buffer	5358	FDA UDI	Class II	Active
SPIFE Nexus (120/230V)	1650000	FDA UDI	Class I	Active
Arachidonic Acid	5364	FDA UDI	Class II	Active
Actalyke Thermometer	5757000	FDA UDI	Class I	Active
Blade Applicator Kit, 20 Sample	552589	FDA UDI	Class II	Active
Blade Applicator Kit, 20 Sample (50)	552593	FDA UDI	Class I	Active
SPIFE Ultra ImmunoFix-15 Gel Kit	552580	FDA UDI	Class II	Active
Square Cuvettes for HemeSpec Plus (500/pkg)	1104000	FDA UDI	Class I	Active
Blade Applicator Kit Split Beta SPIFE 4000	552406	FDA UDI	Class I	Active
Beta-Thal HbA2 Quik Column Kit	5341	FDA UDI	Class II	Active
Titan III Zip Zone Cellulose Acetate (60 x 76 mm)	3023	FDA UDI	Class I	Active
Free Protein S Reagent	5363	FDA UDI	Class II	Active
SPIFE SPE Hi Res-20 Kit	552603	FDA UDI	Class I	Active

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FDA Recalls (16)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 2, 2023	Z-1975-2023	—	open, classified	Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result.
Apr 6, 2022	Z-1244-2022	—	open, classified	Due to microbial growth causing interference with interpretation.
Jan 5, 2021	Z-1108-2021	—	terminated	Intermittent potential for shorter than expected clot times.
Nov 9, 2020	Z-0635-2021	—	open, classified	Due to complaints received associated with cracked/split test tube caps.
Aug 8, 2018	Z-1950-2019	—	open, classified	The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
Aug 8, 2018	Z-1949-2019	—	open, classified	The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
May 23, 2018	Z-0536-2020	—	open, classified	Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit may contain particulate matter or microbial growth.
May 23, 2018	Z-0537-2020	—	open, classified	Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet aggregation Kit, may contain particulate matter or microbial growth.
Feb 27, 2018	Z-0297-2020	—	open, classified	Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users.
Dec 7, 2017	Z-2761-2019	—	terminated	Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
Jul 21, 2017	Z-0045-2020	—	terminated	The plates do not have wells punched for the controls in the patient 1 area.
Apr 4, 2017	Z-0106-2019	—	terminated	Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as Protein S conjugate.
Feb 24, 2017	Z-0561-2019	—	terminated	Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.
Nov 7, 2016	Z-0529-2019	—	terminated	Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.
Oct 14, 2016	Z-2434-2019	—	terminated	Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
Apr 20, 2016	Z-0594-2019	—	terminated	Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected