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Omega Medical Electronics

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Devices
21

What Omega Medical Electronics makes

Omega Medical Electronics manufactures reagent sets for clinical chemistry testing, including enzymatic uric acid, serum calcium, SGOT (AST), SGPT (ALT), hemoglobin, total protein, total bilirubin, creatinine, alkaline phosphatase, direct glucose, and urea nitrogen assays. These products are designed for use in laboratory analyzers to measure key biochemical markers in serum or plasma samples.

The company’s reagent sets are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. Products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue21

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  • Sgot Reagent Set Ref K821209

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

  • Uric Acid Reagent Set(Enzymatic Ref K821214

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

  • Serum Calcium Reagent Set Ref K821196

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

  • Sgpt-Uv Reagent Set Ref K821206

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

  • Hemoglobin Reagent Set Ref K821202

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

  • Serum Total Protein Reagent Set Ref K821210

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

  • Uric Acid Reagent Set Ref K821213

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

  • Total Bilirubin Reagent Set Ref K821197

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

  • Creatinine Reagent Set Ref K821199

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

  • Alkaline Phosphotase Reagent Set Ref K821200

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

  • Direct Glucose Reagent Set Ref K821198

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

  • Urea Nitrogen Reagent Set Ref K821212

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

  • Cholesterol Reagent Set Ref K821195

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

  • Sgot-Uv Reagent Set Ref K821208

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

  • Triglyceride Reagent Set Ref K821205

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

  • Hdl Precipitant Reagent Set Ref K821203

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

  • Ldh-Uv Reagent Set Ref K821201

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

  • Glucose(Enzymatic) Reagent Set Ref K821204

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

  • Sgpt Reagent Set Ref K821207

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

  • Albumin Reagent Set Ref K821193

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

  • Phosphorus Reagent Set Ref K823691

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

Rows 1-21 of 21

Frequently asked questions

How many devices does Omega Medical Electronics have in the registry?

The registry currently lists 21 devices for Omega Medical Electronics. Devices recorded under merged duplicate company entries are counted once.

Which registries list Omega Medical Electronics's devices?

Among its 21 most recently registered devices, Omega Medical Electronics has devices listed in FDA 510(k) (21 devices).

What risk classes do Omega Medical Electronics's devices fall under?

Among its 21 most recently registered devices, the classes recorded for Omega Medical Electronics's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Omega Medical Electronics in the registry?

The most recently registered devices listed for Omega Medical Electronics include SGOT REAGENT SET, URIC ACID REAGENT SET(ENZYMATIC, SERUM CALCIUM REAGENT SET and SGPT-UV REAGENT SET.

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