Skip to content

American Bioproducts Co.

Country not established

Devices
79

What American Bioproducts Co. makes

American Bioproducts Co. manufactures in vitro diagnostic (IVD) test kits for coagulation and hemostasis parameters, including assays for tissue plasminogen activator (TPA), platelet factor 4 (PF4), von Willebrand factor (VWF), protein C, antithrombin, and activated factor VIII. Their portfolio also includes kits for heparin monitoring, low-molecular-weight heparin (LMWH), and plasma-based assays for factor VIII deficiency. Additional products cover protein C and plasminogen activator inhibitor (antiplasmin) testing, designed for laboratory use in blood coagulation analysis.

The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory clearance obtained through the 510(k) pathway. These products are listed in the FDA’s 510(k) database and are intended for use in the United States. No other regulatory registries or jurisdictions are specified.

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

Catalogue79

Newest first, rows 51-79 of 79

Search and filter all 79 devices
Skip device list

  • Ptt-Lt Test Kit Ref K941210

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

  • Liatest(R) At Iii Test Kit Ref K905110

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

  • Stago Factor Xii-Deficient Plasma Ref K933438

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

  • Asserachrom Protein S Test Kit Ref K872479

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

  • Asserachrom Total Protein S Kit Ref K954040

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

  • The Stachrom Heparin Assay Kit Ref K925433

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

  • Neoplastine(R) Ci Kit Ref K922565

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

  • Asserachrom Fpa Kit Ref K854384

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

  • At-Iii Control Plasma Kit Ref K955040

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

  • Fdp Plasma Test Kit Ref K920943

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

  • Neoplastine Ci Plus Ref K922040

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

  • Thrombin-Prest Reagent Kit Ref K884384

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

  • Protein S Control Plasma Ref K870917

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

  • Heparin Control Kit Ref K943520

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

  • Sta D-Di Calibrator Kit Ref K964718

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

  • Sta-Vwf Calibrator Kit Ref K962671

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

  • Stago Factor Xi-Deficient Plasma Ref K933444

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

  • Asserachrom Protein C Kit Ref K854016

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

  • Staclot(R) Protein S Test Kit Ref K913424 Open recall

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

  • Sta-Coag Control [P] Plus Kit Ref K952338

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

  • Sta Liatest Control [N]+[P] Kit Ref K964716

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

  • Stachrom Antiplasmin Test Kit Ref K882602

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

  • Coag-Control [N] Kit Ref K922174

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

  • Thrombo-Calibrator Kit Ref K921344

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

  • Sta Automated Multi-Parametric Analyzer Ref K942117

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

  • Sta Compact Automated Multi-Parametric Analyzer Ref K961579

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

  • Assera-Plate Protein S Kit Ref K870042

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

  • Coag-Control Ref K930923

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

  • Assera-Plate Protein C Kit Ref K861475

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

Rows 51-79 of 79

Showing 51-79 of 79