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Biopool AB

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Devices
13

What Biopool AB makes

Biopool AB manufactures in vitro diagnostic (IVD) test kits and reagents for coagulation and fibrinolysis analysis, including latex agglutination tests, enzyme immunoassays (EID), and chromogenic assays. Their products detect biomarkers such as D-dimer, antithrombin III (ATIII), protein C, protein S, von Willebrand factor (VWF), plasminogen, heparin, and tissue plasminogen activator (TPA). Some kits are designed for bulk plate production, enabling laboratory-scale testing.

The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the FDA’s 510(k) clearance registry. Products are intended for use in clinical laboratories for diagnostic purposes. Biopool AB is based in the United States.

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

Catalogue13

Newest first, rows 1-13 of 13

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  • Minutex D-Dimer Latex Test Ref K920668

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

  • Spectrolyse Atiii Kit Ref K902530

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

  • Biopool Protein C Eid Kit And Bulk Plates Ref K902566

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

  • Bioclot C Kit Ref K902528

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

  • Biopool Vwf Eld Kit And Vwf Eld Bulk Plates Ref K942087

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

  • Protein S Eid Kit And Protein S Eid Bulk Plates Ref K915163

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

  • Spectrolyse/Pl Pai Kit Ref K922782

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

  • Tintelizer(R) Tpa Ref K934314

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

  • Bioclot La Ref K932463

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

  • Spectrolyse Plasminogen Sk Kit Ref K912025

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

  • Spectrolyse Heparin Kit Ref K923499

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

  • Spectrolyse Protein C Kit Ref K914307

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

  • Spectrolyse Antiplasmin Kit Ref K941752

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

Rows 1-13 of 13

Frequently asked questions

How many devices does Biopool AB have in the registry?

The registry currently lists 13 devices for Biopool AB. Devices recorded under merged duplicate company entries are counted once.

Which registries list Biopool AB's devices?

Among its 13 most recently registered devices, Biopool AB has devices listed in FDA 510(k) (13 devices).

What risk classes do Biopool AB's devices fall under?

Among its 13 most recently registered devices, the classes recorded for Biopool AB's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Biopool AB in the registry?

The most recently registered devices listed for Biopool AB include MINUTEX D-DIMER LATEX TEST, SPECTROLYSE ATIII KIT, BIOPOOL PROTEIN C EID KIT AND BULK PLATES and BIOCLOT C KIT.

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