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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 8 of 14

Device	Model / Reference	Registries	Class	Status
ProtoFluor Z (110V)	2005002	FDA UDI	Class I	Active
ColoScreen Developer	500091	FDA UDI	Class II	Active
SPIFE Lipoprotein Gel Kit	551991	FDA UDI	Class I	Active
ImmunoFix Antisera Kit II	3151	FDA UDI	Class II	Active
Amido Black Protein Stain (powder)	3048	FDA UDI	Class I	Active
Cascade M-4 (110V/220V)	1711000	FDA UDI	Class II	Active
SPIFE IFE Applicator Kit	552124	FDA UDI	Class II	Active
V8 Nexus CE Analyzer (115V/230V)	1825000	FDA UDI	Class II	Active
o-Dianisidine (Powder) (1 x 2 g)	5036	FDA UDI	Class I	Active
SPIFE Alkaline Phosphatase-20, 40 Gel Kit	552395	FDA UDI	Class II	Active
V8 Serum Protein SPE Kit (500 tests)	1805	FDA UDI	Class I	Active
Spife 3000, "ce 2011" (230v)	1089002	FDA UDI	Class I	Active
V8 Gel IFE Diluent Barcode Labels	1821	FDA UDI	Class II	Active
Blade Applicator Kit, Spife 4000 Ife	552400	FDA UDI	Class I	Active
Blade Applicator Kit, 20 Sample	552591	FDA UDI	Class II	Active
Factor VII Deficient Substrate Plasma	5192	FDA UDI	Class II	Active
Antiserum to Human Lambda Light Chain	9257	FDA UDI	Class II	Active
Helena Fibrinogen Calibrator	5379	FDA UDI	Class II	Active
ColoScreen III Mailing Envelopes	1002	FDA UDI	Class II	Active
Blade Applicator Kit, 20 Sample	551648	FDA UDI	Class II	Active
ColoScreen Tape	5079	FDA UDI	Class II	Active
TITAN GEL IEP Kit (10 gels)	3047	FDA UDI	Class I	Active
Blade Applicator Kit, 12 Sample	552597	FDA UDI	Class II	Active
QUICKGEL SPE Gel Kit	552304	FDA UDI	Class I	Active
PermaClear Clearing Solution	4950	FDA UDI	Class I	Active
Antiserum to Human IgE	9250	FDA UDI	Class II	Active
Development Weight	5014000	FDA UDI	Class I	Active
Actalyke XL, Dual Detection, (New Display) "CE" (110V/220V)	5770001	FDA UDI	Class II	Active
SPIFE 4000 IFE Antisera Pipette Tips	2304	FDA UDI	Class I	Active
QUICKGEL Cholesterol Gel Kit	552003	FDA UDI	Class I	Active
Titan Gel Rep Ldh-6 Hv	K874145	FDA 510(k)	Class II	Active
Columnmate Ii	K921676	FDA 510(k)	Class II	Active
Afsc Hemo Control #5331, Aa2 Hemo Control #5328	K933086	FDA 510(k)	Class II	Active
Spife Ck Kit, Model 3332, 3333	K022757	FDA 510(k)	Class II	Active
Titangel High Resolution Control	K833639	FDA 510(k)	Class I	Active
Ristocetin Cofactor Assay	K840329	FDA 510(k)	Class II	Active
Titan Gel Rep Simultaneous Ck-Ld Isoenzyme Proced.	K874140	FDA 510(k)	Class II	Active
Columnmate Ii Ghb Affinity Regenerable Column	K946274	FDA 510(k)	Class II	Active
Glyco-Tek Affinity Column Kit	K921305	FDA 510(k)	Class II	Active
Rep Spe Plus (ponceau S) System, 3163, 3164 & 3165	K912386	FDA 510(k)	Class I	Active
Cascade 480(tm) Auto Coag Analyzer, Modification	K914946	FDA 510(k)	Class II	Active
Helena Bio Strip Ob	K834456	FDA 510(k)	Class II	Active
Ab-Trol Ii Coagulation Control Plasm Cat. No. 5183	K905673	FDA 510(k)	Class II	Active
Rocket Reference Plasma, Cat No. 5188	K900019	FDA 510(k)	Class II	Active
Titan Gel Cpk Rep System	K873399	FDA 510(k)	Class II	Active
Helena Biostrip A	K830978	FDA 510(k)	Class I	Active
Rep Lipo Kit Cat. No 3180	K881809	FDA 510(k)	Class I	Active
Rep Sp Electrophoresis System Cat No. 3170	K881852	FDA 510(k)	Class I	Active
Edc/Titan Geliso-Total Cpk Isoenzyme Procedure	K852392	FDA 510(k)	Class II	Active
Rep Spe Plus (acid Blue) System	K911468	FDA 510(k)	Class I	Active

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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