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Reagent Laboratory, Inc.

United StatesFDA applicant, unverified

Devices
19

What Reagent Laboratory, Inc. makes

Reagent Laboratory, Inc. manufactures laboratory reagents and solutions for clinical chemistry, hematology, and microbiology testing. These include electrolyte standards (sodium, potassium), urine diluents, hemolysis prevention agents, and electrolyte-specific rinses. Staining solutions for cytology and microbiology, such as methylene blue-eosin and Gram stain, are also part of the portfolio, alongside specialized reagents like cyanomethemoglobin and lithium-based solutions.

The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. These reagents and solutions are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.

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

Catalogue19

Newest first, rows 1-19 of 19

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  • Lysing & Hemoglobin Reagent Ref K841800

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

  • Sodium & Potassium Standard Solut Ref K841419

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

  • Volume Test Dye 6 Ref K841422

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

  • Urine Diluent-For Use With Ion Selective Electrode Ref K860143

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

  • Hemolyse Ref K863503

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

  • Potassium Chloride Solution -2 Molar Ref K841417

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

  • Lithium Reagent Ref K841847

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

  • Sodium Electrode Rinse Solution 2 Ref K841418

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

  • Stain, Methylene Blue-Eosin Ref K842785

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

  • Cyanomethemoglobin Reagent Ref K841799

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

  • Wrights Stain Solution Ref K843051

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

  • Gram Stain Ref K843050

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

  • Scotts Tap Water Substitute 7 Ref K841423

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

  • Sodium Chloride Solution Blood Cell Ref K841183

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

  • Potassium Hydroxide 10% W/V Ref K863550

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

  • Formalin Buffered Ref K842982

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

  • Daily Wash Solution 5 Ref K841421

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

  • Sodium & Potassium Standard Sol 80 Ref K841420

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

  • Solution B- Na 50MEQ/L, K 40 Meq/L Ref K863502

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

Rows 1-19 of 19

Frequently asked questions

How many devices does Reagent Laboratory, Inc. have in the registry?

The registry currently lists 19 devices for Reagent Laboratory, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Reagent Laboratory, Inc.'s devices?

Among its 19 most recently registered devices, Reagent Laboratory, Inc. has devices listed in FDA 510(k) (19 devices).

What risk classes do Reagent Laboratory, Inc.'s devices fall under?

Among its 19 most recently registered devices, the classes recorded for Reagent Laboratory, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Reagent Laboratory, Inc. in the registry?

The most recently registered devices listed for Reagent Laboratory, Inc. include LYSING & HEMOGLOBIN REAGENT, SODIUM & POTASSIUM STANDARD SOLUT, VOLUME TEST DYE 6 and URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE.

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