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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 11 of 14

Device	Model / Reference	Registries	Class	Status
Rep Hemoglobin Ief Kits (cat. No. 3250)	K931503	FDA 510(k)	Class II	Active
Spife Ld-12 Kit, Model 3338	K022455	FDA 510(k)	Class II	Active
Rep 3 Quto-Flur Cholesterol-30	K962914	FDA 510(k)	Class I	Active
Permaclear Solution Cat. No. 4950	K861490	FDA 510(k)	Class I	Active
Glycosylated Hemoglobin-Smc Column	K802233	FDA 510(k)	Class II	Active
Rep Alkaline Hb-15 #3196, -8 #3197, -4 3198	K931465	FDA 510(k)	Class II	Active
Coloscreen V.p.i.	K832864	FDA 510(k)	Class II	Active
Rep Hdl Electrophoresis Method	K882368	FDA 510(k)	Class I	Active
Helena Colocare	K882799	FDA 510(k)	Class II	Active
Titan Gel Glyco-Heme System	K832087	FDA 510(k)	Class II	Active
Rep Ultra Hdl, Vldl/Ldl Cholesterol System	K904035	FDA 510(k)	Class I	Active
Columnmate Beta-Thal Hba2 Control - Normal	K923318	FDA 510(k)	Class II	Active
Rep Spe Plus (acid Blue) System, # 3173/3174/3175	K922024	FDA 510(k)	Class I	Active
Specialty Assayed Control-2	K100103	FDA 510(k)	Class II	Active
Cascade 480(tm) Automated Coagulation Analy. 1430	K901380	FDA 510(k)	Class II	Active
Titan Gel Immunofix-9 Cat. No. 3051 And 3067	K931247	FDA 510(k)	Class II	Active
Rocket Reference Plasma, Cat. No. 5188, Modified	K911777	FDA 510(k)	Class II	Active
Ab-Trol Coagulation Control	K802232	FDA 510(k)	Class II	Active
Titan Gel Cpk/Ldh Isoenzyme Control	K821981	FDA 510(k)	Class I	Active
Fetal Maturity Test Procedure	K790798	FDA 510(k)	Class II	Active
Titan Gel-Pc Glyco-Heme(tm) System	K880698	FDA 510(k)	Class II	Active
Spife 2000/3000 Lipoprotein; Model# 3340, 3341, 3342, 3343	K013466	FDA 510(k)	Class I	Active
Rep Ck Isoforms Kit Cat. No. 3081, 3082, 3083	K896170	FDA 510(k)	Class II	Active
Titan Gel Iso Dot Cpk Procedure	K842755	FDA 510(k)	Class II	Active
Bio Sure Stain	K832496	FDA 510(k)	Class I	Active
Helena Biostrip Ph	K830979	FDA 510(k)	Class I	Active
Rep(tm) Ck-2 Stat Kit, Cat. No. 3074	K893007	FDA 510(k)	Class II	Active
Automated Electrophoresis System	K803281	FDA 510(k)	Class I	Active
Biostrip G	K820594	FDA 510(k)	Class II	Active
V8 Sp Normal Control, Abnormal Control	K131479	FDA 510(k)	Class I	Active
Titan Gel Rep Cpk-12 Hv	K874146	FDA 510(k)	Class II	Active
Helena Factor Ix Deficient Substrate	K792475	FDA 510(k)	Class II	Active
Actalyke Qc Kit, Models Aqc-Hp And Aqc-Lp	K061014	FDA 510(k)	Class II	Active
Titan Gel High Resolution Serum Protein	K821688	FDA 510(k)	Class I	Active
Cellulose Acetate-Citrate Agar Hemoglo	K813395	FDA 510(k)	Class II	Active
Adp Reagent, Modified	K952252	FDA 510(k)	Class II	Active
Labile Lysing Reagent	K884315	FDA 510(k)	Class II	Active
Rep Cholesterol Profile Template-30, -16, -8; Rep Vis Cholesterol	K980650	FDA 510(k)	Class I	Active
Rep Alp-15, 8, & 4 Kits	K912603	FDA 510(k)	Class II	Active
Hbf-Quiplate Methodology	K780807	FDA 510(k)	Class II	Active
Adp Reagent	K910800	FDA 510(k)	Class II	Active
Helena Biostrip P	K830977	FDA 510(k)	Class I	Active
Helena Factor Xi Deficient Substrate	K792476	FDA 510(k)	Class II	Active
Alkaline Phosphatase Indolyl Blue Reagent	K870890	FDA 510(k)	Class II	Active
Titan Gel Immunofix Kit, Cat. No. 3046	K900422	FDA 510(k)	Class II	Active
Helena Hemoglobin F Controls	K810475	FDA 510(k)	Class II	Active
Chrom Z Chromogenic Assays	K951943	FDA 510(k)	Class II	Active
Electrophoresis Data Center (edc)	K860645	FDA 510(k)	Class I	Active
Activat-Partial Thrombo-Plastin	K830320	FDA 510(k)	Class II	Active
Coagulation Arp	K790826	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