Skip to content

Biorent Diagnostic, Inc.

United StatesFDA applicant, unverified

Devices
11

What Biorent Diagnostic, Inc. makes

Biorent Diagnostic, Inc. manufactures reagent sets and reagents for clinical chemistry testing, including optimized UV-based assays for enzymes like GOT, LDH, and CK, as well as colorimetric methods for uric acid, cholesterol, albumin, hemoglobin, and glucose. Their products are designed for laboratory use in measuring biochemical markers in patient samples.

The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded via the 510(k) pathway. These products are intended for use in the United States and are listed in the FDA’s regulatory database.

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

Catalogue11

Newest first, rows 1-11 of 11

Search and filter all 11 devices
Skip device list

  • Optimized Uv-Gpt Reagent Set Ref K822494

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

  • Colorimetric Ldh Reagent Set Ref K820768

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

  • Uv Uric Acid Determination Ref K813244

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

  • Cholesterol Determination Ref K811760

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

  • Optimized Uv-Got Reagent Set Ref K822493

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

  • Optimized Uv-Ldh Reagent Set Ref K822492

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

  • Colorimetric Uric Acid Reagent Set Ref K820632

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

  • Albumin Reagent Set Ref K832747

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

  • Ck-Uv Reagent Ref K823211

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

  • Hemoglobin Reagent Ref K823060

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

  • Glucose Enzyme-Color Reagent Set Ref K813555

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

Rows 1-11 of 11

Frequently asked questions

How many devices does Biorent Diagnostic, Inc. have in the registry?

The registry currently lists 11 devices for Biorent Diagnostic, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Biorent Diagnostic, Inc.'s devices?

Among its 11 most recently registered devices, Biorent Diagnostic, Inc. has devices listed in FDA 510(k) (11 devices).

What risk classes do Biorent Diagnostic, Inc.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Biorent Diagnostic, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Biorent Diagnostic, Inc. in the registry?

The most recently registered devices listed for Biorent Diagnostic, Inc. include OPTIMIZED UV-GPT REAGENT SET, COLORIMETRIC LDH REAGENT SET, UV URIC ACID DETERMINATION and CHOLESTEROL DETERMINATION.

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