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Bioclone Australia Pty, Ltd.

Country not established

Devices
10

What Bioclone Australia Pty, Ltd. makes

Bioclone Australia Pty Ltd manufactures enzyme-linked immunosorbent assay (ELISA) kits for clinical diagnostics, including tests for hormones such as follicle-stimulating hormone (FSH), thyroid-stimulating hormone (TSH), prolactin, and human chorionic gonadotropin (HCG), as well as ferritin and immunoglobulin E (IgE). Their products are designed for neonatal and adult serum/plasma analysis, supporting laboratory measurements of thyroid function, fertility markers, and iron storage levels.

The company’s ELISA kits are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. These products are listed in the FDA’s 510(k) database, indicating their compliance with U.S. medical device regulations. The manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue10

Newest first, rows 1-10 of 10

  • Elegance Gh Elisa Ref K905098

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

  • Bioclones Elegance Fsh Elisa Kit Ref K904405

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

  • Elegance FT4 Elisa Ref K922284

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

  • Bioclone's Elegance Ige Elisa Kit Ref K910419

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

  • Elegance Neonatal Tsh Elisa Ref K935049

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

  • Elegance Prolactin Elisa Ref K904483

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

  • Bioclone's Elegance Hcg Elisa Kit Ref K910420

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

  • Elegance Tsh Elisa Ref K905099

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

  • Elegance Ferritin Elisa Ref K904822

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

  • Bioclones Elegance Lh Elisa Kit Ref K904387

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

Frequently asked questions

How many devices does Bioclone Australia Pty, Ltd. have in the registry?

The registry currently lists 10 devices for Bioclone Australia Pty, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bioclone Australia Pty, Ltd.'s devices?

Among its 10 most recently registered devices, Bioclone Australia Pty, Ltd. has devices listed in FDA 510(k) (10 devices).

What risk classes do Bioclone Australia Pty, Ltd.'s devices fall under?

Among its 10 most recently registered devices, the classes recorded for Bioclone Australia Pty, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Bioclone Australia Pty, Ltd. in the registry?

The most recently registered devices listed for Bioclone Australia Pty, Ltd. include ELEGANCE GH ELISA, BIOCLONES ELEGANCE FSH ELISA KIT, ELEGANCE FT4 ELISA and BIOCLONE'S ELEGANCE IGE ELISA KIT.

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