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Sign in to claim this brandHelena Laboratories, Corp.
US
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?
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.
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
- facebook.com/HelenaLaboratories
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1618982
- DUNS Number
- —
Catalogue (662)
Page 13 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Helena Biostrip K | K830976 | FDA 510(k) | Class I | Active |
| Factor Viii Reference Plasma | K880292 | FDA 510(k) | Class II | Active |
| Chrom-Trol | K872377 | FDA 510(k) | Class II | Active |
| Aptt-Es | K935169 | FDA 510(k) | Class II | Active |
| A, Fda2 Lyophilized Hemo Control | K800856 | FDA 510(k) | Class II | Active |
| Hep-Trol | K801932 | FDA 510(k) | Class II | Active |
| Titan Gel Serum Control | K821982 | FDA 510(k) | Class I | Active |
| Actalyke Mini Activated Clotting Time Test System, Model 5750/5752 | K013078 | FDA 510(k) | Class II | Active |
| Titan Gel Alkaline Phosphatase (hr) | K921578 | FDA 510(k) | Class II | Active |
| Rep Immunofix | K923658 | FDA 510(k) | Class II | Active |
| Polyslit Ife Kit | K990998 | FDA 510(k) | Class II | Active |
| Cardio Rep Ck Isoenzyme Kit - 3310 | K931050 | FDA 510(k) | Class II | Active |
| Titan Gel Multi-Slot Sp-17 Kit Cat. No. 3091 | K870958 | FDA 510(k) | Class I | Active |
| Rep Direct-Sep Cholesterol-15 Kit; Cholesterol-8 Kit; Cholesterol-4 Kit | K935162 | FDA 510(k) | Class I | Active |
| Rep Lipo-8 Kit, No. 3182/Rep Lipo-16 Kit, No. 3181 | K893223 | FDA 510(k) | Class I | Active |
| Specialty Assayed Control-1 | K941737 | FDA 510(k) | Class II | Active |
| Rep Glyco-8 Kit, #3208/Rep Glyco-16 Kit, #3207 | K893224 | FDA 510(k) | Class II | Active |
| Helena Plasminogen Quiplate Procedure | K811777 | FDA 510(k) | Class I | Active |
| Helena Coloscreen Method | K812428 | FDA 510(k) | Class II | Active |
| Thromboplastin-Li Reagent | K951820 | FDA 510(k) | Class II | Active |
| Glyco Hb Quik Column Procedure | K823869 | FDA 510(k) | Class II | Active |
| V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control | K192931 | FDA 510(k) | Class II | Active |
| Helena Coloscreen Self-Test | K840903 | FDA 510(k) | Class II | Active |
| Colocare | K905798 | FDA 510(k) | Class II | Active |
| Helena Vma-Smc Column Method | K810992 | FDA 510(k) | Class I | Active |
| Rep(tm) Ld-2 Stat Kit, Cat. No. 3078 | K892818 | FDA 510(k) | Class II | Active |
| Owren's Veronal Buffer #5375 & Fibronogen Kit#5376 | K926222 | FDA 510(k) | Class II | Active |
| Helena Quiplate System | K790646 | FDA 510(k) | Class I | Active |
| Coloscreen | K911075 | FDA 510(k) | Class II | Active |
| Quik Column Methodology | K790583 | FDA 510(k) | Class II | Active |
| Titan Immuno-Fix | K830594 | FDA 510(k) | Class II | Active |
| Rep(tm) Spe Temp-30-16-8 Procedure, 3170, 3171, 3172 | K913058 | FDA 510(k) | Class I | Active |
| Spife Lipporotein-12, Model 3344 | K022333 | FDA 510(k) | Class I | Active |
| Protofluor Z | K893038 | FDA 510(k) | Class I | Active |
| Helena Thromboplastin Reagent, Modification | K905857 | FDA 510(k) | Class II | Active |
| Rep E-Z Ck-30 Isoenzyme Kit | K925801 | FDA 510(k) | Class II | Active |
| Chromogenic System Analyzer Spectrophotometer Csa | K873384 | FDA 510(k) | Class I | Active |
| Titan Gel Multi-Slot Lipo-17 System | K871319 | FDA 510(k) | Class I | Active |
| Tip Top(r) Dispenser Caps | K896670 | FDA 510(k) | Class I | Active |
| Hbf Diluent | K880653 | FDA 510(k) | Class II | Active |
| Coagulation Arpr, Cat.no.5185 | K914949 | FDA 510(k) | Class II | Active |
| Chrom Z-Plasminogen, Cat. No. 5244 | K952669 | FDA 510(k) | Class II | Active |
| Spife | K972274 | FDA 510(k) | Class I | Active |
| Rep Spe Vis-60/40 Kit | K973316 | FDA 510(k) | Class I | Active |
| Helena Vma-Smc Control | K811912 | FDA 510(k) | Class I | Active |
| Spife 3000 Titan Gel Igg Ief Kit, Model 3389 | K024162 | FDA 510(k) | Class II | Active |
| Cardio Rep-Cat. No. 1400 & Ck Isoforms Kit 3305 | K930359 | FDA 510(k) | Class II | Active |
| Spife Ife-15 Pentavalent, Model 3456, Spife Ife-9 Pentavalent Kit, Model 3457, Spift Ife-6 Pentavalent Kit, Model 3458 | K061069 | FDA 510(k) | Class II | Active |
| Helena Factor Vii Deficient Sub. Plasma | K792511 | FDA 510(k) | Class II | Active |
| Lyophilized Hdl Cholesterol Controls | K792025 | FDA 510(k) | Class I | 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 |