Siemens Healthcare Diagnostics, Inc.

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 59 건

  • 모델명 / 제조번호(시리얼번호)
    Catalog Number KS850 - lots: X05-076-11, X05-081-11, X05-086-11, X05-090-11, X05-091-11, X05-096-11, X05-101-11, X05-108-11, X05-117-11, X05-122-11, X05-125-11, and X05-126-11.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and Puerto Rico., and the countries of Austria, Belgium, France, Germany, Italy, The Netherlands, Portugal, Spain, Switzerland, Australia, Japan, South Korea, and Canada.
  • 제품 설명
    Dimension Vista(R) Cuvettes || The Dimension Vista(R) Cuvettes are for use on the Dimension Vista(R) System. The Dimension Vista(R) integrated system is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid. Vista (TM) system chemical and immunochemical applications utilize photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion selective multisensor technology for clinical use.
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: K6451; Mnemonic: TPSA; lot number 11300BB, exp 10/26/2012
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    USA Nationwide Distribution including the states of: AL, AZ, CA, CO, CT, FL IL, LA, MD, MI, MN, MS, MT, NC, NH, NJ, NV, NY, OH, PA, SD, TN, TX, UT, WI ,WV including Puerto Rico.
  • 제품 설명
    Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge || Product Usage: || The TPSA method is an in vitro diagnostic test for the quantitative measurement of total prostate specific antigen (PSA) in human serum and plasma on the Dimension Vista(R) System
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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.
  • 모델명 / 제조번호(시리얼번호)
    Lots 12135AE and 12171BB
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) including the states of AL, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and WI.
  • 제품 설명
    Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) || The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system.
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: RF421C; Lot Number: FB9037. Expires February 6, 2009.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- Including countries of the United States, Bahamas, Belgium, Czech Republic, France, Germany, Italy, Poland, Portugal, Saudi Arabia, Spain, South Korea, and Slovakia.
  • 제품 설명
    Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). || The CTNI method for the Dimension Clinical Chemistry System with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk of stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
하나 더 54 건 더

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 14 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • 제조사 모회사 (2017)
  • Source
    USFDA
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • 제조사 모회사 (2017)
  • Source
    USFDA
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, Po Box 6101, Newark DE 19702-2466
  • 제조사 모회사 (2017)
  • Source
    USFDA
하나 더 9 건 더