Siemens Healthcare Diagnostics, Inc

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Description

99 dispositivos en la base de datos

  • Modelo / Serial
    Kit lots ending in:  380 Exp Date 2016-10-21;  382/ 2017-01-09; 384 2017-02-06; 386 2017-03-24 ; 388 2017-05-14 ; 390 2017-06-12 .  And all future lots until the issue is resolved. Siemens will also include a notecard in future lots of reagents referring customers to the communications.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Germany, Great Britain, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, Vatican City, Vietnam
  • Descripción del producto
    ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. || Siemens Material Number(SMN): 10491244 || In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is being marketed on the XPT following FDAs Reagent Replacement Policy. Siemens plans to request CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016.
  • Modelo / Serial
    Kit lots ending in: 380 Exp Date 2016-10-21;  382/ 2017-01-09; 384 2017-02-06; 386 2017-03-24 ; 388 2017-05-14 ; 390 2017-06-12 .  And all future lots until the issue is resolved. Siemens will also include a notecard in future lots of reagents referring customers to the communications .
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Germany, Great Britain, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, Vatican City, Vietnam
  • Descripción del producto
    ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. || Siemens Material Number(SMN): 10491379 || In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is being marketed on the XPT following FDAs Reagent Replacement Policy. Siemens plans to request CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016.
  • Modelo / Serial
    All lot codes
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Foreign: Afghanistan, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Georgia, Germany, Great Britain, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Italy, Japan, Jordan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Serbia, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, Uruguay, Vietnam
  • Descripción del producto
    Siemens ADVIA Centaur¿ Vitamin D Total Assay || SMN SMN 10699533 (500 test)
  • Modelo / Serial
    All lot codes
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Foreign: Afghanistan, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Georgia, Germany, Great Britain, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Italy, Japan, Jordan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Serbia, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, Uruguay, Vietnam
  • Descripción del producto
    Siemens ADVIA Centaur¿ Vitamin D Total Assay || SMN 10699201 (100 test)
  • Modelo / Serial
    Lot 038174: 100 Test - 43305174 and 43278174; 500 Test - 43306174 and 43279174.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide including Puerto Rico; and countries of: Canada, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Fren.Polynesia, Germany, Great Britain, Greece, Guadeloupe, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Reunion, Russian Fed., Slovakia, Slovenia, Spain, Switzerland, Turkey, Unit.Arab Emir., AR, AU, BR, CL, CN, CR, IN, JP, KR, LK, MY, SG, TW, UY, VN, and ZA.
  • Descripción del producto
    ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: || Cat No. 02816138/SMN 10309044 (100 test) || 02816634/SMN 10309045 (500 test)
94 más

17 fabricantes con un nombre similar

Más información acerca de la data acá

  • Empresa matriz del fabricante (2017)
  • Source
    MHRB
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, Po Box 6101, Newark DE 19702-2466
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA
  • Empresa matriz del fabricante (2017)
  • Source
    AEMPSVFOI
12 más