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Electro-Nucleonics Laboratories, Inc.

United StatesFDA applicant, unverified

Devices
41

What Electro-Nucleonics Laboratories, Inc. makes

Electro-Nucleonics Laboratories, Inc. manufactures diagnostic reagents and systems for detecting antibodies, pathogens, and biochemical markers. Their portfolio includes enzyme-linked immunoassays (such as Toxoplasma gondii IgG ELISA and herpes identification/typing tests), biochemical assays (e.g., lipase hydrolysis/glycerol kinase for triglycerides), and automated reagent dispensing systems (e.g., Multi-Access Reagent Dispenser). Additional offerings include immunoassay kits for herpesvirus and Chlamydia trachomatis antibodies, as well as standalone diagnostic systems like the GEMSTAR and STARLYTE.

The company’s diagnostic products are classified under FDA’s Class I and Class II categories, with most requiring 510(k) clearance. Their devices are listed in the FDA’s 510(k) registry, reflecting regulatory compliance for in vitro diagnostic use. The manufacturer operates from the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue41

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  • Lipase Hydrolysis/Glycerol Kinase, Triglycerides Ref K863874

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Toxoplasma Gondii Igg Elisa Ref K871905

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Gemeni Igm Assay Ref K800450

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Herpes Ident. & Typing Test Hitt Ref K831504

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Gemeni Igg Assay Ref K800451

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Gemstar System Ref K821335

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Antibody To Herpesvirus Hominis Ref K791058

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Starlyte Ref K832744

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Delta Trol I & Ii Ref K853373

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Multi-Access Reagent Dispenser Ref K873416

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Antibody To Chlamydia Trachomatis Ref K811570

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Gemeni Ast-Lts Reagents Ref K851267

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Creatine Kinase Reagent Ck Lts Ref K831965

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Riause Auto Processor Ref K801030

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Virgo Ipa For Detection Of Gentamicin Ref K811744

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Virgo Ipa For Detection Of Phenytoin Ref K811745

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Virgo Immuno-Precipitation Assay Tobra Ref K821542

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Gemeni Iga Assay Ref K800449

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Gemeni Uric Acid U.V. Ref K873358

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Antibody To Respiratory Syncytial Virus Ref K831924

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Autoloader Ii Ref K843779

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Virgo(Tm) Measles Igg Elisa Ref K873925

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Virgo(Tm) Rubella Igg Elisa Ref K873088

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Antibody To Rubella Virus Ref K792635

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cholesterol (Total) Analysis Products Ref K870928

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Detection Of Theophylline Ref K821544

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Virgo Reagents Indirect Fluorscent Ref K841127

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Gemstar Ii System Ref K873617

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Flexigram Auto Loader System Ref K811525

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Eni Blood Urea Nitrogen Reagent Ref K844065

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Amylase Lts Ref K862640

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ipa For Detection Of Phenobarbital Ref K821543

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Antibody To Varicella-Zoster Virus Ref K800787

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Antibody To Mumps Virus Ifa Test Ref K822826

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Eni Antibody To Measles(Rubeola) Virus Ref K821249

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Gemeni Gpt (Alt) Assay Ref K761269

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Gemstar Ipa Theophylline Test Kit Ref K853372

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Acclaim Ref K832648

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Alt -Lts Ref K832639

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Eni Antibody To Epstein-Barr Virus Ref K810860

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ifa Anti-Ndna Ref K771376

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-41 of 41

Frequently asked questions

How many devices does Electro-Nucleonics Laboratories, Inc. have in the registry?

The registry currently lists 41 devices for Electro-Nucleonics Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Electro-Nucleonics Laboratories, Inc.'s devices?

Among its 41 most recently registered devices, Electro-Nucleonics Laboratories, Inc. has devices listed in FDA 510(k) (41 devices).

What risk classes do Electro-Nucleonics Laboratories, Inc.'s devices fall under?

Among its 41 most recently registered devices, the classes recorded for Electro-Nucleonics Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Electro-Nucleonics Laboratories, Inc. in the registry?

The most recently registered devices listed for Electro-Nucleonics Laboratories, Inc. include LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES, TOXOPLASMA GONDII IGG ELISA, GEMENI IGM ASSAY and HERPES IDENT. & TYPING TEST HITT.

Generated automatically from registry data and not verified by a human reviewer.