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Intersect Systems, Inc.

United StatesFDA applicant, unverified

Devices
21

What Intersect Systems, Inc. makes

Intersect Systems, Inc. manufactures enzymatic and reagent-based diagnostic products for clinical laboratory testing, including glucose oxidase reagents, triglyceride and cholesterol assay kits, bilirubin and enzyme-specific reagents (such as amylase, CK-NAC, and GGT), and carbon dioxide measurement reagents. The company also produces the MINI-PECG, a device for point-of-care coagulation testing, alongside chloride and albumin reagents for serum chemistry analysis.

The portfolio includes devices classified under FDA’s Class I and Class II categories, with regulatory submissions recorded via the 510(k) pathway. These products 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, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue21

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  • Glucose Oxidase Reagent Ref K870616

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

  • Intersect Systems Direct Amylase Reagent Ref K932888

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

  • Intersect Systems Triglyceride-Gpo Reagent Ref K870827

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

  • Enzymatic CO2 Reagent, Modification Ref K932267

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

  • Carbon Dioxide Reagent Ref K881169

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

  • Mini-Pecg Ref K832883

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

  • Gamma Glutamyltransferase Reagent Ref K871979

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

  • Total Bilirubin Reagent Ref K003892

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

  • Ck-Nac Reagent Ref K974833

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

  • Chloride Reagent Ref K911297

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

  • Intersect Systems Hdl Cholesterol Reagent Set Ref K934039

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

  • Albumin Reagent Ref K021636

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

  • Glucose-Hk Reagent Ref K873835

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

  • Mini Pecg-Modification Ref K841148

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

  • Direct Bilirubin Reagent Ref K011972

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

  • Homogeneous Enzymic Homocysteine Reagent Ref K011692

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

  • Intersect Systems Enzymatic Cholesterol Reagent Ref K870828

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

  • Dif-Stet Ref K832882

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

  • Dual Vial Creatinine Reagent Ref K983937

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

  • Urine/Csf Microprotein Reagent Ref K913225

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

  • Intersect Systems' Non-Mercuric Chloride Reagent Ref K941807

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

Rows 1-21 of 21

Frequently asked questions

How many devices does Intersect Systems, Inc. have in the registry?

The registry currently lists 21 devices for Intersect Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Intersect Systems, Inc.'s devices?

Among its 21 most recently registered devices, Intersect Systems, Inc. has devices listed in FDA 510(k) (21 devices).

What risk classes do Intersect Systems, Inc.'s devices fall under?

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

What are the newest devices from Intersect Systems, Inc. in the registry?

The most recently registered devices listed for Intersect Systems, Inc. include GLUCOSE OXIDASE REAGENT, INTERSECT SYSTEMS DIRECT AMYLASE REAGENT, INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT and ENZYMATIC CO2 REAGENT, MODIFICATION.

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