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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
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 9 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lipotrol | K792024 | FDA 510(k) | Class I | Active |
| Protofluor Z | K871499 | FDA 510(k) | Class I | Active |
| Titan Gel Ldh Isoenzyme Kit | K821983 | FDA 510(k) | Class II | Active |
| Columnmate(tm) Beta-Thal Cat. No. 4515 | K913384 | FDA 510(k) | Class II | Active |
| Helena Colocheck | K800433 | FDA 510(k) | Class II | Active |
| Helena At-Iii Quiplate Procedure | K802912 | FDA 510(k) | Class II | Active |
| Rep(r) Immunofix | K901805 | FDA 510(k) | Class II | Active |
| Titan Gel Silver Stain System | K833855 | FDA 510(k) | Class I | Active |
| Chrom Z-Heparin, Cat. No 5242 | K952667 | FDA 510(k) | Class II | Active |
| Titan Gel Ldh Iso-Enzyme Control | K830872 | FDA 510(k) | Class II | Active |
| Coagulation A.r.p. | K933277 | FDA 510(k) | Class II | Active |
| Fetal-Tek Control (immature/Borderline) | K820772 | FDA 510(k) | Class I | Active |
| Protein C Antigen Rocket Eid Method No. 5357 | K897136 | FDA 510(k) | Class II | Active |
| Kemtrol Serum Control-Normal Cat No. 7024 | K920927 | FDA 510(k) | Class I | Active |
| Titan Gel Iso Dot Ldh Kit | K842669 | FDA 510(k) | Class II | Active |
| Spife 2000/3000 Alp 40, 20; Models 3345 And 3346 | K020625 | FDA 510(k) | Class II | Active |
| Rep Hdl-8 Kit, No. 3188, Rep Hdl-16 Kit, No. 3187 | K894366 | FDA 510(k) | Class I | Active |
| Spife Alkaline Hemoglobin | K982426 | FDA 510(k) | Class II | Active |
| Specialty Assayed Reference Plasma (s.a.r.p.) | K941860 | FDA 510(k) | Class II | Active |
| Spectro-Sur Set | K791315 | FDA 510(k) | Class II | Active |
| Helena Factor X Deficient Substrate | K792508 | FDA 510(k) | Class II | Active |
| Titan Gel Rep Ldh-30 Hv | K874142 | FDA 510(k) | Class II | Active |
| Thor Henostatsis Analyzer Cat. No. 1450, 1451 | K961908 | FDA 510(k) | Class II | Active |
| Helena Factor Ii Deficient Sub. Plasma | K792336 | FDA 510(k) | Class II | Active |
| Helena Ultra Sensitive Cpk Reagent/Dilue | K801318 | FDA 510(k) | Class II | Active |
| Cat. No. 1471 (110v) & Cat. No. 1472 (220v) | K921465 | FDA 510(k) | Class II | Active |
| Helena Hbf Quiplate Control | K812226 | FDA 510(k) | Class II | Active |
| Biocheck Positive Urine Control | K831994 | FDA 510(k) | Class I | Active |
| Rep Spe Hi-Res System No. 3176, 3177, 3178 | K892424 | FDA 510(k) | Class II | Active |
| Rep Spe Plus (ponceau S) System | K922053 | FDA 510(k) | Class I | Active |
| Surespot | K862701 | FDA 510(k) | Class I | Active |
| Titan Gel Hdl Cholesterol Kit | K873547 | FDA 510(k) | Class I | Active |
| Porcine Factor Viii;c Reagent | K952321 | FDA 510(k) | Class II | Active |
| Plateletworks, Models Pw-A, Pw-C | K023761 | FDA 510(k) | Class II | Active |
| Helena Factor Viii Deficient Sub. Plasma | K792335 | FDA 510(k) | Class II | Active |
| Helena Hba2 Quik Column Method | K803108 | FDA 510(k) | Class II | Active |
| Rapid Electrophoresis System (rep) | K873352 | FDA 510(k) | Class I | Active |
| Thrombin Clotting Time Reagent | K920147 | FDA 510(k) | Class II | Active |
| Chrom Z-Protein C, Cat. No. 5243 | K952666 | FDA 510(k) | Class II | Active |
| Liquid Thromboplastin Reagent | K830331 | FDA 510(k) | Class II | Active |
| Glyco-Tek Affinity Column | K842689 | FDA 510(k) | Class II | Active |
| Titanan Gel Serum Protein Electrophores | K821517 | FDA 510(k) | Class I | Active |
| Coloscreen-Es | K980671 | FDA 510(k) | Class II | Active |
| Biosure | K840848 | FDA 510(k) | Class I | Active |
| Titan Gel Ife Trivalent Antiserum | K891188 | FDA 510(k) | Class II | Active |
| Cardio Rep Recombinant Ck Abnormal Control | K932442 | FDA 510(k) | Class I | Active |
| Beta Thalquik Column #5341 | K823870 | FDA 510(k) | Class II | Active |
| Titan Gel Alkaline Phosphatase (hr) | K885341 | FDA 510(k) | Class II | Active |
| Rep Spe Hi-Res Template System, Cat 3276/3277/3278 | K930317 | FDA 510(k) | Class I | Active |
| Mid-Level Igg Kit Cat. No. 9315 | K891299 | FDA 510(k) | Class I | 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 |