Devices

Device Recall Presage ST2 Assay

  • Modelo / Serial
    BC-1065 (US distribution) Lot No. RN-43116-4 BC-1065 E (European Distribution) Lot No. RN-42467-1, RN-42467-2, RN-43116-1, RN-43116-2, RN-43116-3.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA including the state of California and the countries of Austria, Spain, United Kingdom, and Italy.
  • Descripción del producto
    Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. || The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
  • Manufacturer
    Critical Diagnostics
  • 1 Event

Fabricante

Critical Diagnostics
  • Dirección del fabricante
    Critical Diagnostics, 3030 Bunker Hill St Ste 115a, San Diego CA 92109-5754
  • Empresa matriz del fabricante (2017)
    Critical Diagnostics Inc.
  • Source
    USFDA