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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 10 of 14

Device	Model / Reference	Registries	Class	Status
Titan Gel Ife Free Kappa/Lamba Light Chain Antiser	K891683	FDA 510(k)	Class II	Active
Titan Gel Ife Antiserum To Igd-9409 & Ige-9410	K872834	FDA 510(k)	Class II	Active
Pentavalent Antiserum To Human Immunoglobulins	K871352	FDA 510(k)	Class II	Active
Rep Cholesterol Profile Kit	K992971	FDA 510(k)	Class I	Active
Rep Glyco Control Normal(3209) And Abnormal(3210)	K900017	FDA 510(k)	Class II	Active
Free Protein S Reagent Cat. No. 5363	K904247	FDA 510(k)	Class II	Active
Kemtrol Serum Control-Normal	K802108	FDA 510(k)	Class I	Active
Rep Hemoglobin Ief Kits (cat. No. 3250)	K901143	FDA 510(k)	Class II	Active
Cascase 480 Snslyzer	K951497	FDA 510(k)	Class II	Active
Fetal-Tek Control Mature	K820319	FDA 510(k)	Class I	Active
Rep 3 Flur Spe-60 Kit	K964453	FDA 510(k)	Class I	Active
Helena Thromboplastin-Mi Reagent	K940310	FDA 510(k)	Class II	Active
Spife Cholesterol Profile Kit	K000603	FDA 510(k)	Class I	Active
Helena Glycosylated Hemoglobin Quik Meth	K800857	FDA 510(k)	Class II	Active
SPIFE A1AT kit	K213396	FDA 510(k)	Class II	Active
Helena Coloscreen	K792655	FDA 510(k)	Class II	Active
Lyophilized G-Hb Quik Column Control	K791135	FDA 510(k)	Class II	Active
Rep Spe-8 Kit, Cat.# 3172/Rep Spe-16 Kit Cat.#3171	K893211	FDA 510(k)	Class I	Active
Helena Fetal-Tek 200 Method	K811588	FDA 510(k)	Class II	Active
Rep Hdl/Ldl-30 Kit - Cat. No. 3220, 3221, 3222	K940679	FDA 510(k)	Class I	Active
Helena Hemoglobin Detect Column Sys	K820573	FDA 510(k)	Class II	Active
Helena Hemespec Ii Total Hemoglobin Met.	K803016	FDA 510(k)	Class II	Active
Cardio Rep Ld Control - Cat No. 3325	K950801	FDA 510(k)	Class I	Active
Protein S Antigen Rocket Eid Kit, Cat. No. 5359	K896174	FDA 510(k)	Class II	Active
Bufferizer	K791144	FDA 510(k)	Class I	Active
Rep(tm) Spe Plus-16 (ponceau S) And (amido)	K901463	FDA 510(k)	Class I	Active
Rep Cholesterol Profile Control-Ii	K974609	FDA 510(k)	Class I	Active
Cardio Rep Ck Calibrators 1 & 2 Cat. No. 3322 & 3323	K932768	FDA 510(k)	Class II	Active
Cascade 480	K921363	FDA 510(k)	Class II	Active
Hemespec Ii	K803015	FDA 510(k)	Class II	Active
Helena Abnormal Hba2 Quik Column Control	K820787	FDA 510(k)	Class II	Active
Helena Factor V Deficient Substrate	K792507	FDA 510(k)	Class II	Active
Kemtrol Serum Control-Abnormal	K920926	FDA 510(k)	Class I	Active
Factor Viii Related Antigen Rocket Eid	K823267	FDA 510(k)	Class II	Active
Actalyke Xl Activated Clotting Time Analyzer, Model 5770	K020914	FDA 510(k)	Class II	Active
Helena Rep Gel Processor	K882163	FDA 510(k)	Class I	Active
Rep(r) Spe Template 30, 16, & 8	K913807	FDA 510(k)	Class I	Active
Helena Ristocetin	K800432	FDA 510(k)	Class II	Active
Titan Gel Rep Ldh-12 Hv	K874143	FDA 510(k)	Class II	Active
Aves Wright Stain	K820437	FDA 510(k)	Class I	Active
Spife Ife Calibrator And Control Kit	K010617	FDA 510(k)	Class II	Active
Collagen Reagent Cat. No. 5368	K910706	FDA 510(k)	Class II	Active
Modification Columnmate	K920820	FDA 510(k)	Class II	Active
Helena Sickle-Thal Quik Column Method	K812077	FDA 510(k)	Class II	Active
Hemespec Check Set	K800852	FDA 510(k)	Class II	Active
Chrom-Trol Cat. No. 5300 W/ New Analyte	K902083	FDA 510(k)	Class II	Active
Kemtrol Serum Control Abnormal	K802109	FDA 510(k)	Class I	Active
Titan Gel Lipoprotein Electrophoresis	K833611	FDA 510(k)	Class I	Active
Epinephrine Reagent, Cat. No. 5367	K910680	FDA 510(k)	Class II	Active
Helena Thromboplastin Reagent	K892050	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

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Importers

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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