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Biologics Intl., Inc.

United StatesFDA applicant, unverified

Devices
9

What Biologics Intl., Inc. makes

Biologics Intl., Inc. manufactures diagnostic slide tests for immunology and infectious disease, including the BI-ASO, BI-RA, and ANA Latex Slide Tests for detecting antibodies. The company also produces the BETA-CELL and CARCINO-CEK tests for specific biomarker detection, as well as the BE-SURE pregnancy test. Additionally, it supplies pressure-relief and wound care systems like the Air Bed & Flotation Dermagard 800 & 900 and the PREG-TEX wound dressing.

The company’s portfolio includes devices classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) clearance registry. These products are listed under U.S. jurisdiction, adhering to FDA requirements for medical device authorisation.

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

Catalogue9

Newest first, rows 1-9 of 9

  • Air Bed & Flotation Dermagard 800 & 900 Systems Ref K882229

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

  • Preg-Tex Ref K790898

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

  • Bi-Aso Slide Test Ref K812060

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

  • Bi-Ra Slide Test Ref K811375

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

  • Ana Latex Slide Test Ref K800605

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

  • Beta-Cell Ref K791607

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

  • Carcino-Cek Ref K823353

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

  • Bi-Crp Latex Test Ref K811374

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

  • Be-Sure Ref K791609

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

Frequently asked questions

How many devices does Biologics Intl., Inc. have in the registry?

The registry currently lists 9 devices for Biologics Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Biologics Intl., Inc.'s devices?

Among its 9 most recently registered devices, Biologics Intl., Inc. has devices listed in FDA 510(k) (9 devices).

What risk classes do Biologics Intl., Inc.'s devices fall under?

Among its 9 most recently registered devices, the classes recorded for Biologics Intl., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Biologics Intl., Inc. in the registry?

The most recently registered devices listed for Biologics Intl., Inc. include AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS, PREG-TEX, BI-ASO SLIDE TEST and BI-RA SLIDE TEST.

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