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Tech-Neal Scientific, Inc.

United StatesFDA applicant, unverified

Devices
20

What Tech-Neal Scientific, Inc. makes

Tech-Neal Scientific, Inc. manufactures reagent sets and individual reagents for clinical chemistry testing, including ALT (SGPT), creatine kinase (CK), glucose, triglycerides, urea nitrogen (BUN), magnesium, total bilirubin, uric acid, creatinine, total protein, cholesterol, and AST (SGOT). These products are designed for use in automated and semi-automated laboratory analyzers to measure key biochemical parameters in patient samples.

The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products cleared via the 510(k) pathway. These reagents are intended for in vitro diagnostic use and are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.

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

Catalogue20

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  • Alt (Sgpt) Reagent Set Ref K880275

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

  • Creatine Kinase (Ck) Reagent Set Ref K881237

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

  • Glucose Hexokinase Ref K880236

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

  • Triglyceride Ref K880238

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

  • Urea Nitrogen (Bun) Ref K880078

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

  • Magnesium Reagent Set Ref K882256

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

  • Total Bilirubin Reagent Ref K881241

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

  • Uric Acid Reagent Set Ref K880277

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

  • Creatinine Reagent Set (Kinetic) Ref K880843

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

  • Total Protein Reagent Set Ref K880677

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

  • Cholesterol Ref K880237

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

  • Ast (Sgot) Reagent Set Ref K880276

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

  • Diazo, Colorimetric Bilirubin Ref K882459

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

  • Inorganic Phosphorus Reagent Set Ref K880676

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

  • Ldh-L Reagent Set Ref K880842

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

  • Alkaline Phosphatase Reagent Set Ref K880307

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

  • Albumin Reagent Set Ref K880844

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

  • Chloride Reagent Set Ref K881240

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

  • Calcium Reagent Set Ref K880845

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

  • Gamma Glutamyl Transferase Reagent Set Ref K881239

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

Rows 1-20 of 20

Frequently asked questions

How many devices does Tech-Neal Scientific, Inc. have in the registry?

The registry currently lists 20 devices for Tech-Neal Scientific, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Tech-Neal Scientific, Inc.'s devices?

Among its 20 most recently registered devices, Tech-Neal Scientific, Inc. has devices listed in FDA 510(k) (20 devices).

What risk classes do Tech-Neal Scientific, Inc.'s devices fall under?

Among its 20 most recently registered devices, the classes recorded for Tech-Neal Scientific, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Tech-Neal Scientific, Inc. in the registry?

The most recently registered devices listed for Tech-Neal Scientific, Inc. include ALT (SGPT) REAGENT SET, CREATINE KINASE (CK) REAGENT SET, GLUCOSE HEXOKINASE and TRIGLYCERIDE.

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