Is this your brand? Sign in to claim ownership.

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 2 of 14

Device	Model / Reference	Registries	Class	Status
QuickGel IFE Blotter A and Templates	552156	FDA UDI	Class II	Active
SPIFE IgG IEF-10 Kit	552457	FDA UDI	Class II	Active
Ponceau S (1 x 105 g powder)	5526	FDA UDI	Class I	Active
IFE IgD Antiserum	9419	FDA UDI	Class II	Active
SPIFE Nexus IFE-9/15 Antisera Kit	552744	FDA UDI	Class II	Active
ColoScreen 1000 Slide Pack	5076	FDA UDI	Class II	Active
Titan IV Citrate Agar Plate	2400	FDA UDI	Class II	Active
Plateletworks Combo-15 Kit	5850	FDA UDI	Class II	Active
Thromboplastin-LI Reagent Kit	5249	FDA UDI	Class II	Active
ColoScreen III Lab Pack	5082	FDA UDI	Class II	Active
QuickGel Applicator Blade and Shallow Well Cups	552134	FDA UDI	Class II	Active
Blade Applicator Kit, 20 Sample (40)	552592	FDA UDI	Class I	Active
Blade Applicator Kit, 20 Sample	551674	FDA UDI	Class II	Active
SPIFE IgG IEF-20 Reagent Kit	552202	FDA UDI	Class II	Active
Tips for IFE-9 Multi-Channel Pipette (rack of 384)	3397	FDA UDI	Class I	Active
Actalyke QC Kit - AQC-LP	AQC-LP	FDA UDI	Class II	Active
SPIFE ImmunoFix-15 Gel Kit	552559	FDA UDI	Class II	Active
QuickGel LD Gel Kit	552397	FDA UDI	Class II	Active
ProtoFluor Z (110V)	2005000	FDA UDI	Class I	Active
Helena Ristocetin	5199	FDA UDI	Class II	Active
SPIFE ImmunoFix-3 Gel Kit	552560	FDA UDI	Class II	Active
SPIFE Split Beta SPE-80, 100 Gel Kit	552582	FDA UDI	Class I	Active
C-ACT Tubes	C-ACT	FDA UDI	Class II	Active
H-Pette with Blade (1000 pieces)	3612	FDA UDI	Class I	Active
Collagen Reagent	5368	FDA UDI	Class II	Active
Actalyke Mini II, w/o Printer & Battery, "CE 2009" (110V/220V)	5755001	FDA UDI	Class II	Active
Helena Thrombin Reagent	5374	FDA UDI	Class II	Active
Protein C Antigen Rocket Kit	5357	FDA UDI	Class II	Unknown
Scale Set Solutions for AggRAM & PACKS-4 Platelet Assays	1479	FDA UDI	Class I	Active
SPIFE 4000 IFE Sample Trays	2305	FDA UDI	Class I	Active
Lyophilized Platelets	5371	FDA UDI	Class II	Active
Siliconized Cuvettes for AggRAM & PACKS-4	1473	FDA UDI	Class I	Active
Coagulation S.A.C.-1 (Specialty Assay Control)	5301	FDA UDI	Class II	Active
SPIFE IFE Multi-Channel Pipette	1122000	FDA UDI	Class I	Active
SPIFE ImmunoFix-6 Gel Kit	552583	FDA UDI	Class II	Active
SPIFE Ultra ImmunoFix-15 Antisera Kit	552125	FDA UDI	Class II	Active
APTT-SA (Soluble Activator) Reagent Kit	5388	FDA UDI	Class II	Active
Plateletworks Combo-25 Kit	5852	FDA UDI	Class II	Active
SPIFE Hemoglobin IEF Kit	3428	FDA UDI	Class II	Unknown
Coagulation S.A.R.P (Specialty Assayed Reference Plasma)	5185	FDA UDI	Class II	Active
SPIFE 4000 Acid Hemoglobin Kit	2322	FDA UDI	Class II	Active
AFSC Hemo Control	5331	FDA UDI	Class II	Active
Titan III Lipo (60 x 76 mm)	3900	FDA UDI	Class I	Active
Titan Gel ImmunoFix Kit	3046	FDA UDI	Class II	Active
Coolant Sponges (10/pkg)	5045	FDA UDI	Class I	Active
APTT-SA (Soluble Activator) Reagent Kit	5389	FDA UDI	Class II	Active
V8 SP Abnormal Control (10 x 2 mL)	1811	FDA UDI	Class I	Active
AFSA2 Hemo Control	5330	FDA UDI	Class II	Active
Blade Applicator Kit, 18 Sample	552595	FDA UDI	Class II	Active
SPIFE 4000 IFE Antisera Kit	552440	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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