Ortho-Clinical Diagnostics

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Description

131 dispositivos en la base de datos

  • Modelo / Serial
    01-5919, Exp. 5/31/2005 (EXPIRED):  01-6032, Exp. 9/30/2005 (EXPIRED); and 02-6284, Exp. 1/28/2006
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product shipped to medical facilities (end-users) in the U.S. and to 9 International J&J; affiliates in Australia, Canada, Caribbean, Chile, France, Philippines, Portugal, Taiwan, UK/Northern Europe, Israel, Saudi Arabia and Venezuela.
  • Descripción del producto
    VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626
  • Modelo / Serial
    Software Versions 3.6.1 and below; Affected US Serial Numbers: 5GV6W2J,GBX395J, J2QKG25J, 2Z3YV1J, 3RHC23J, 4HX7S4J, 54FC01J, 5J4B45J, 736BM4J, 7KSC15J, J86PWC5J, 953209, 953221, 953266, 953270, B3ZHP2J, CXL941J, JFBX395J, FCM073J, FXCBG3J, JG7BFB5J, GWXQ52J, HJ5K84J, HPKG25J -- Affected Foreign Serial Numbers: DWXO52J, GWJZY4J, J16XQH4J, BGV6W2J, 17QP94J, 4SHPF4J, 1K5K84J, 37QP34J, H5PWC5J, J2V6LW4J, F6MXR3J, JT6LW4J, N0551107, F1150698, 46XQH4J, 2S5OP0J, CRKM82, J41BCY4J, J56T205J, BGV6W2J, 7YCF43J, 96XQHAJ, C1JNZ5J, C3JTP4J, D3JTP4J, 86T205J, 18BFB5J, 96PWC5J, 1LSSF5J, 4drj44j, 8W7WG3J, J953222, J953244, JCT20Q3J, HWJZY4J, 38769917923.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-(Nationwide) and foreign distribution to the following countries: Belgium, Bermuda, Canada, Chile, Denmark, France, Italy, Mexico, Norway, Portugal, Sweden, Taiwan and United Kingdom.
  • Descripción del producto
    enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Module has Product Code || 952040-EG 6844097. || The VITROS 5,1 FS Chemistry System with enGen Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).
  • Modelo / Serial
    Software Versions 2.2.1 through 2.8; Catalog # 6801375 Serial Numbers: 34000119 through 34002323; Catalog # 6801890 Serial Numbers: J34000133, J34000193, J34000197, J34000212, J34000285, J34000316, J34000318, J34000337, J34000360, J34000420, J34000451, J34000478, J34000495, J34000497, J34000529, J34000538, J34000552, J34000557, J34000590, J34000596, J34000601, J34000631, J34000642, J34000761, J34000799, J34000805, J34000833, J34000851, J34000893, J34000946, J34000947, J34001006, J34001172, J34001218, J34001240, J34001243, J34001248, J34001251, J34001274, J34001297, J34001311, J34001317, J34001345, J34001378, J34001379, J34001389, J34001390, J34001396, J34001422, J34001472, J34001504, J34001569, J34001572, J34001612, J34001626, J34001633, J34001668, J34001755, J34001809, J34001840, J34001850, J34001875, J34001897.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.
  • Descripción del producto
    VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644. Intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest.
  • Modelo / Serial
    Software Version 3.0 and below; Serial Numbers J56000110 - J56001995 (serial numbers are sequential; J Numbers are analogous to serial numbers)
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
  • Descripción del producto
    VITROS 5600 Integrated System, System Product Code 6802413. || For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
  • Modelo / Serial
    Software Version 3.0 and below; Serial Numbers J46000012 - J46000456 (serial numbers are sequential; J Numbers are analogous to serial numbers)
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
  • Descripción del producto
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. || The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.
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