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Hana Biologics, Inc.

United StatesFDA applicant, unverified

Devices
8

What Hana Biologics, Inc. makes

Hana Biologics, Inc. manufactures in vitro diagnostic devices for microbiological and serological testing, including triphasic culture systems for fungal isolates, agglutination tests for amniotic fluid, and colorimetric assays for antigen detection. Their portfolio also includes specialized culture media and supplements for fungal and bacterial growth, as well as diagnostic reagents for blood typing and immune response evaluation.

The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) database. These products are intended for laboratory use in the United States and comply with applicable U.S. regulatory requirements for in vitro diagnostics.

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

Catalogue8

Newest first, rows 1-8 of 8

  • Mycotrim Tm Vl Triphasic Culture System Ref K855205

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

  • Mycotrium-Gu Ref K822736

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

  • Amnistat-Flm Ref K822150

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

  • Mycotrium-Rs Ref K822737

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

  • Amnio Stat-Flm Agglutination Test Ref K834616

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

  • Ace Color Test Ref K833933

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

  • Chang Medium Ref K812820

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

  • Chang Medium (Additional Indications) Ref K883682

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

Frequently asked questions

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

The registry currently lists 8 devices for Hana Biologics, Inc.. Devices recorded under merged duplicate company entries are counted once.

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

Among its 8 most recently registered devices, Hana Biologics, Inc. has devices listed in FDA 510(k) (8 devices).

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

Among its 8 most recently registered devices, the classes recorded for Hana Biologics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Hana Biologics, Inc. include MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM, MYCOTRIUM-GU, AMNISTAT-FLM and MYCOTRIUM-RS.

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