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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

What Helena Laboratories, Corp. makes

Helena Laboratories manufactures in vitro diagnostic devices including protein electrophoresis kits and reagents, faecal occult blood test kits, platelet aggregation study reagents, coagulation analyzers, densitometry analyzers, and electrophoresis analyzers.

The company's products are classified as Class I and Class II medical devices and are listed in the FDA Unique Device Identification (UDI) registry. Helena Laboratories is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What medical devices does Helena Laboratories manufacture?

Where is Helena Laboratories based?

Helena Laboratories is based in the United States, as indicated by the country information provided in the device data.

Which regulatory registries list Helena Laboratories' devices?

Helena Laboratories' devices are listed in the FDA Unique Device Identification (UDI) registry, as specified in the device data.

How are Helena Laboratories' devices classified?

Helena Laboratories' devices are classified as Class I and Class II medical devices, according to the device classification information provided.

AI-generated from registry data and not verified by a human reviewer.

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 4 of 14

Device	Model / Reference	Registries	Class	Status
Titan IV IEPlates	9061	FDA UDI	Class II	Active
SPIFE Nexus Split Beta SPE - 80, 100 Gel Kit	552693	FDA UDI	Class I	Active
Zip Zone Chamber Wicks (500/pkg)	5081	FDA UDI	Class I	Active
Antiserum to Human Serum	9233	FDA UDI	Class II	Active
Actalyke QC Kit - AQC-HP	AQC-HP	FDA UDI	Class II	Active
Factor II Deficient Substrate Plasma	5190	FDA UDI	Class II	Active
QuickScan 2000 (Windows 2000) Version 2.02 and small Scanner	1660003	FDA UDI	Class I	Active
IFE IgD Antiserum	9409	FDA UDI	Class II	Active
SPIFE ImmunoFix-3/6 Urine Accessory Kit	552388	FDA UDI	Class II	Active
SPIFE Nexus IFE-9 Gel Kit	552695	FDA UDI	Class II	Active
SPIFE 4000 IFE Gel Kit	552398	FDA UDI	Class II	Active
ProtoFluor Glass Slides	2001	FDA UDI	Class I	Active
Protein S Antigen Rocket Kit	5359	FDA UDI	Class II	Active
AB-TROL 2 Coagulation Control	5187	FDA UDI	Class II	Active
Electra HR Buffer	5805	FDA UDI	Class II	Active
QuickScan Touch Software & Key	1691000	FDA UDI	Class I	Active
Antisera to Human Immunoglobulins Pentavalent (G, A, M, D, E)	9251	FDA UDI	Class II	Active
ASA2 Hemo Control	5329	FDA UDI	Class II	Active
V8 Velocity CE Analyzer (110V) Not Inpeco Ready	1800000	FDA UDI	Class II	Active
Gel Alk Phosphatase Isoenzyme Control (1 x 2 mL)	5104	FDA UDI	Class I	Active
QuickScan Touch, V800	1690001	FDA UDI	Class I	Active
ColoScreen III Take Home Pack	5073	FDA UDI	Class II	Active
SPIFE Lipoprotein Gel Kit	552608	FDA UDI	Class I	Active
Spife Spe Hi Res 20 Kit	552471	FDA UDI	Class I	Active
Factor VIII Deficient Substrate Plasma	5193	FDA UDI	Class II	Active
SPIFE 4000, Windows 7 (100V)	1622003	FDA UDI	Class I	Active
Plateletworks ADP Kit	5860	FDA UDI	Class II	Active
SPIFE Split Beta SPE-20, 40, 60 Gel Kit	552564	FDA UDI	Class I	Active
SPIFE 3000 w/ New Pump & Valve (110V)	1088001	FDA UDI	Class I	Active
QuickScan 2000 (Windows 2000) Version 2.02 and V700 Scanner	1660004	FDA UDI	Class I	Active
SPIFE IFE-3/6 Disposable Sample Cups	3368	FDA UDI	Class I	Active
Blade Applicator Kit, Modified-20 Sample (40)	552051	FDA UDI	Class I	Active
REP Prep Solution	3100	FDA UDI	Class I	Active
AggRAM Analyzer, Windows 2000 (110V/220V)	1484000	FDA UDI	Class II	Active
ColoScreen iFOBT Cassettes	5062	FDA UDI	Class II	Active
TITAN GEL IEP Stain (1 x 10 g powder)	3049	FDA UDI	Class I	Active
Blade Applicator Kit, Modified-20 Sample (50)	552050	FDA UDI	Class I	Active
QuickScan 2000, (WINDOWS 2000)	1660002	FDA UDI	Class I	Active
V8 E-Class Velocity CE Analyzer (220V)	1801000	FDA UDI	Class II	Active
Titan IV IEPlates	9050	FDA UDI	Class II	Active
REP Cholesterol Profile Control (5 x 1 mL)	3218	FDA UDI	Class I	Active
SPE Normal Control (10 x 2 mL)	3424	FDA UDI	Class I	Active
Clear Aid	5005	FDA UDI	Class I	Active
H-Pette Remover	3613	FDA UDI	Class I	Active
Supre-Heme Buffer	5802	FDA UDI	Class II	Active
SPIFE Vis Cholesterol Kit	551919	FDA UDI	Class I	Active
QuickGel Disposable Sample Cups - Deep Well	1259	FDA UDI	Class I	Active
V8 SP Normal Control (10 x 2 mL)	1810	FDA UDI	Class I	Active
Sickle-Thal Quik Column Kit	5334	FDA UDI	Class II	Active
Hemolysate Reagent	5125	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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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.

Helena Laboratories, Corp. has 16 recall records initiated between 2016-04-20 and 2023-05-02, with statuses recorded as open, classified, and terminated. The reasons for recall include issues such as enzyme activity not being in range, particulate matter or microbial growth in reagents, mislabeled internal components, assay range variations, variations in test results, positive control reactivity issues, cracked test tube caps, and missing wells in plates.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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