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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

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 6 of 14

Device	Model / Reference	Registries	Class	Status
Titan Gel ImmunoFix Antisera Kit	3068	FDA UDI	Class II	Active
SPIFE Ultra ImmunoFix-6 Antisera Kit	552163	FDA UDI	Class II	Active
Antiserum to Human IgG	9232	FDA UDI	Class II	Active
Tips for IFE-6/3 Multi-Channel Pipette (10 pks of 72)	3402	FDA UDI	Class I	Active
Neutral Density Densitometer Control for SPIFE 4000	1033000	FDA UDI	Class I	Active
Actalyke XL, (CSA/CE), New Display #2 (110V/220V)	5770003	FDA UDI	Class II	Active
SPIFE ImmunoFix-15 Applicator Kit	552092	FDA UDI	Class II	Active
AggRAM Module (110/220 V)	1487000	FDA UDI	Class II	Active
ProtoFluor Reagent System (Part 1 of 2)	551056	FDA UDI	Class I	Active
SPIFE CK Reagent Kit	552028	FDA UDI	Class II	Active
Zip Zone Applicator	4080	FDA UDI	Class I	Active
1000 Staining Set	5122	FDA UDI	Class I	Active
Coagulation S.A.C.-2 (Specialty Assay Control)	5302	FDA UDI	Class II	Active
SPIFE Alkaline Hemoglobin Gel Kit	551977	FDA UDI	Class II	Active
AB-Trol 3 Coagulation Control	5183	FDA UDI	Class II	Active
Factor XI Deficient Substrate Plasma	5196	FDA UDI	Class II	Active
V8 Velocity CE Analyzer (110V) Inpeco Ready	1800001	FDA UDI	Class II	Active
IFE Free Kappa Light Chain Antiserum	9412	FDA UDI	Class II	Active
SPIFE ImmunoFix-3 Antisera Kit	551832	FDA UDI	Class II	Active
ColoScreen-ES Lab Pack	5086	FDA UDI	Class II	Active
Quik Column Equipment Kit	5336	FDA UDI	Class I	Active
SPIFE 4000 Applicator Blades	2319	FDA UDI	Class I	Active
ColoScreen iFOBT Collection Tubes	5061	FDA UDI	Class II	Active
SPIFE 4000 Split Beta SPE-28 Kit	2310	FDA UDI	Class I	Active
Disposable Pipette Tips (1-200 microliter)	1475	FDA UDI	Class I	Active
AggRAM Analyzer, Windows 7 (110V/220V)	1484002	FDA UDI	Class II	Active
Antiserum to Human IgD	9249	FDA UDI	Class II	Active
Alkaline Phosphatase Indolyl Blue Reagent Kit	5102	FDA UDI	Class II	Active
ADP Reagent	5366	FDA UDI	Class II	Active
TITAN GEL Alkaline Phosphatase Reagent Kit	551031	FDA UDI	Class II	Active
Electrophoresis Handler, CE Version	1341000	FDA UDI	Class I	Active
SPIFE ImmunoFix-6 Antisera Kit	551822	FDA UDI	Class II	Active
Factor IX Deficient Substrate Plasma	5194	FDA UDI	Class II	Active
V8 Storage Buffer Kit	1831	FDA UDI	Class I	Active
IFE IgE Antiserum	9420	FDA UDI	Class II	Active
SPIFE Alkaline Phosphatase Gel Kit	552604	FDA UDI	Class II	Active
H-Pette II (No Blade, Metal Canula) (1000 pieces)	3615	FDA UDI	Class I	Active
Blade Applicator Kit, Modified-20 Sample (20)	552000	FDA UDI	Class I	Active
ColoCare - NR	551547	FDA UDI	Class II	Active
SPIFE IFE-9 Pentavalent Antisera Kit	552229	FDA UDI	Class II	Active
IEP Sponge Wicks (2/pkg)	9015	FDA UDI	Class I	Active
QuickGel Applicator Kit (Applicator, Base, Weights, Cup Tray)	1274000	FDA UDI	Class I	Active
Titan Gel IFE Light Chain Antisera Kit	3069	FDA UDI	Class II	Active
o-Tolidine (Powder) (1 x 2 g)	5041	FDA UDI	Class I	Active
SPIFE Nexus Antisera 9/15 Kit	552697	FDA UDI	Class II	Active
Titan III Cellulose Acetate (76 x 25 mm)	3013	FDA UDI	Class I	Active
Actalyke Mini II, w/ Printer, w/o Battery, "CE" (110V/220V)	5753000	FDA UDI	Class II	Active
ColoScreen-ES Take Home Pack	5085	FDA UDI	Class II	Active
SPIFE ImmunoFix-9 Gel Kit	552563	FDA UDI	Class II	Active
SPIFE CK-20, 40 Gel Kit	552612	FDA UDI	Class II	Active

Related Companies

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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.

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