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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 14 of 14

Device	Model / Reference	Registries	Class	Status
Glyco-Je, E Cpmtrp;-Normal/Abnormal	K833356	FDA 510(k)	Class II	Active
Titan Gel Immunofix Controls	K871498	FDA 510(k)	Class II	Active
Negative Urine Control	K830834	FDA 510(k)	Class I	Active
Titan Gel Rep Cpk-6 Hv	K874144	FDA 510(k)	Class II	Active
Hemafluor Reagent Kit	K860309	FDA 510(k)	Class I	Active
Rep(tm) Spe Plus-30 Procedures	K896572	FDA 510(k)	Class I	Active
A, A2 Lyophilized Hemo Control	K800854	FDA 510(k)	Class II	Active
Titan Gel Rep Cpk-30 Hv	K874139	FDA 510(k)	Class II	Active
Columnmate Beta Thal Hba2 Control-Abnormal	K923317	FDA 510(k)	Class II	Active
Rep Flur Cholesterol-60 Kit	K964471	FDA 510(k)	Class I	Active
Helena Fetal-Tek 200 Marker	K811695	FDA 510(k)	Class I	Active
Rep Tm Spe (ponceau S) Procedures	K894585	FDA 510(k)	Class I	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