Stratus(R) CS Acute care(TM) NT

  • Model / Serial
    Lot numbers 211214002, exp 04/28/2012; 211227002, exp 05/11/2012; 211283002, 07/06/2012; 211297002, 07/20/2012; 211339002, 08/31/2012; 212003002, exp 09/29/2012; and 212023002, exp 10/19/2012.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: AK, AR, CA, CO, CT, DC, FL, HI, ID, IN, IL, IA, KS, KY, LA, ME, MI, MN, MS, MO, MT, NE, NH, NM, ND, NY, OH, OK, OR, PA, SD, TX, UT, VT, WA, WV, WI, and WY.
  • Product Description
    Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) || The Stratus(R) CS Acute care(TM) NT - proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT0proBNP) in heparinized plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patient with acute coronary syndrome and heart failure.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Manufacturer Parent Company (2017)
  • Source
    USFDA