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.
Catalogue
Search and filter all 79 devicesShowing 1-50 of 79
Frequently asked questions
How many devices does American Bioproducts Co. have in the registry?
The registry currently lists 79 devices for American Bioproducts Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Bioproducts Co.'s devices?
Among its 50 most recently registered devices, American Bioproducts Co. has devices listed in FDA 510(k) (50 devices).
What risk classes do American Bioproducts Co.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for American Bioproducts Co.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Bioproducts Co. in the registry?
The most recently registered devices listed for American Bioproducts Co. include ASSERACHROM TPA TEST KIT, ASSERACHROM PF4 KIT, ASSERA PLATE IX:AG KIT and ASSERACHROM VWF KIT.