Devices

Hematoxylin II and Horseradish Peroxidase reagents

  • Modèle / numéro de série
    Product Name : GMMI OptiView DAB IHC Detection Kit : 06396500001 ultraView DAB IHC Detection Kit : 05269806001 iView DAB IHC Detection Kit : 05266157001 ultraView SISH Detection Kit : 05271967001 ultraView SISH DNP Detection Kit US : 05572037001 CINtec PLUS Cytology Kit (CE-IVD) : 06889565001 CINtec PLUS Cytology Kit (Canada/Japan): 06889549001 OptiView Amplification Kit : 06396518001 OptiView Amplification Kit (250 Test) : 06718663001 Hematoxylin II : 05277965001 ultraView SISH DNP Detection Kit : 05907136001 EXES VEN IVIEW DAB DET KT JPN-US EXPORT : 05266084001 CINtec PLUS Cytology Kit (US-Export : 06889549001 Multiple Lot numbers of the affected products are provided in attached FSN.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Description du dispositif
    IVD, Reagents
  • Manufacturer
    Roche Diagnostics GmbH
  • 1 Event

Fabricant

Roche Diagnostics GmbH
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Représentant du fabricant
    FAROUK, MAAMOUN TAMER & COMPANY, Riyadh, (011) 4142200
  • Source
    SFDA

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Hematoxylin II and Horseradish Peroxidase reagents
  • Modèle / numéro de série
    Product Name : GMMI OptiView DAB IHC Detection Kit : 06396500001 ultraView DAB IHC Detection Kit : 05269806001 iView DAB IHC Detection Kit : 05266157001 ultraView SISH Detection Kit : 05271967001 ultraView SISH DNP Detection Kit US : 05572037001 CINtec PLUS Cytology Kit (CE-IVD) : 06889565001 CINtec PLUS Cytology Kit (Canada/Japan) : 06889549001 OptiView Amplification Kit : 06396518001 OptiView Amplification Kit (250 Test) : 06718663001 Hematoxylin II : 05277965001 ultraView SISH DNP Detection Kit : 05907136001 NEXES VEN IVIEW DAB DET KT JPN-US EXPORT : 05266084001 CINtec PLUS Cytology Kit (US-Export) : 06889549001 Multiple Lot numbers of the affected products are provided in attached FSN.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Description du dispositif
    In vitro diagnostic devices
  • Manufacturer
    Roche Diagnostics
Hematoxylin II and Horseradish Peroxidase reagents
Dispenser Issues with Hematoxylin II and Horseradish Peroxidase reagents
Dispenser Issues with Hematoxylin II and Horseradish Peroxidase reagents
Hematoxylin II and Horseradish Peroxidase reagents (refer FSN for affected Kits name)
  • Modèle / numéro de série
  • Description du dispositif
    Hematoxylin II and Horseradish Peroxidase reagents (refer FSN for affected Kits name), Ventana Medical Systems Inc.
  • Manufacturer
    Roche Diagnostics Asia Pacific Pte Ltd
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