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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 12 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| A, Fsc Lyophilized Hemo Control | K800855 | FDA 510(k) | Class II | Active |
| Factor Ii Deficient Substrate Plasma | K834031 | FDA 510(k) | Class II | Active |
| Titan Gel Ldh Rep System | K873386 | FDA 510(k) | Class II | Active |
| Helena Factor Xii Deficient | K792656 | FDA 510(k) | Class II | Active |
| Columnmate (automated Column System) 1580, 1581 | K901414 | FDA 510(k) | Class II | Active |
| Scale Set Solutions/405nm Cat#1480-650nm Cat#1479 | K924915 | FDA 510(k) | Class I | Active |
| Acid Hemoglobin Kit | K992199 | FDA 510(k) | Class II | Active |
| Cardio Rep Ld | K940224 | FDA 510(k) | Class II | Active |
| Specialty Assayed Control-2 Cat. No. 5302 | K941872 | FDA 510(k) | Class II | Active |
| Coloscreen-Es | K003359 | FDA 510(k) | Class II | Active |
| Ck/Ld Buffer (cat. No. 5808) | K861750 | FDA 510(k) | Class II | Active |
| Plateletworks Arachidonic Acid, Model Pw-Aca | K061991 | FDA 510(k) | Class II | Active |
| Spife Ife-6 | K973040 | FDA 510(k) | Class II | Active |
| Monitor Iv Plus | K851669 | FDA 510(k) | Class II | Active |
| Titan Ge/Ieplate | K831603 | FDA 510(k) | Class I | Active |
| Rep Cholesterol Profile Control | K950590 | FDA 510(k) | Class I | Active |
| Platelet Aggregation Reagent Set | K832428 | FDA 510(k) | Class II | Active |
| Titan Gel Rep Cpk/Ldh Isoenzyme Control | K874141 | FDA 510(k) | Class I | Active |
| Titan Gel | K905149 | FDA 510(k) | Class II | Active |
| Spife Ld Vis Isoenzyme Kit, Models 3450, 3451, And 3452 | K020467 | FDA 510(k) | Class II | Active |
| Fibrinogen Assay Kit | K841020 | FDA 510(k) | Class II | Active |
| G-Hb Quik Column Control | K790046 | FDA 510(k) | Class II | Active |
| Owren's Veronal Buffer | K883484 | FDA 510(k) | Class II | Active |
| Packs-4 (tm) Analyzer | K912201 | FDA 510(k) | Class II | Active |
| Rapid Electrophoresis Analyzer | K960571 | FDA 510(k) | Class I | Active |
| A, Sa2 Lyophilized Hemo Control | K800853 | FDA 510(k) | Class II | Active |
| Norm-Trol | K792310 | FDA 510(k) | Class II | Active |
| Spife Urine Ife | K982639 | FDA 510(k) | Class II | Active |
| Arachidonic Acid | K912774 | FDA 510(k) | Class II | Active |
| Rep Spe Plus-8 (ponceau S) 3165, Plus-8 No. 3175 | K900251 | FDA 510(k) | Class I | Active |
| Coloscreen Self-Test | K843352 | FDA 510(k) | Class II | Active |
| Immuno Diagnostics Assay | K822026 | FDA 510(k) | Class II | Active |
| Helena Thromboplastin Reagent With Diluent | K905807 | FDA 510(k) | Class II | Active |
| Isopropanol Hemoglobin Stability Test | K822123 | FDA 510(k) | Class II | Active |
| Electrophoresis Work Center (ewc) | K861414 | FDA 510(k) | Class I | Active |
| Hdl Cholesterol Method | K780256 | FDA 510(k) | Class I | Active |
| Rep Glyco System | K881863 | FDA 510(k) | Class II | Active |
| Stirring Assembly For Digispec X Spectro | K822050 | FDA 510(k) | Class I | Active |
| Edc/Titan Geliso-Dot Total Ldh Isoenzyme Procedure | K852391 | FDA 510(k) | Class II | Active |
| Plateletworks | K012723 | FDA 510(k) | Class II | Active |
| Chrom Z-F:viii, Cat. No. 5241 | K952668 | FDA 510(k) | Class II | Active |
| Hemoram/Aggram Analyzer | K050053 | FDA 510(k) | Class II | Active |
| Cascade M, Cat. No. 1710 | K931956 | FDA 510(k) | Class II | Active |
| Pumpette(tm) | K884111 | FDA 510(k) | Class II | Active |
| Gel Alkaline Phosphatase Isoenzyme Control No.5104 | K895528 | FDA 510(k) | Class I | Active |
| Ellagic Acid Aptt Reagent | K915418 | FDA 510(k) | Class II | Active |
| Titan Gel Cpk Isoenzyme System | K822124 | FDA 510(k) | Class II | Active |
| Q.i.c. Bleeding Time Device | K871318 | FDA 510(k) | Class II | Active |
| Auto Aic Analyzer System | K833772 | FDA 510(k) | Class II | Active |
| Hemespec | K782035 | FDA 510(k) | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
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 |