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    375 results · 23ms · Sources: EU EUDAMED, US FDA

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    HER2 CISH PHARMDX KIT

    FDA Adverse Event
    Malfunction ·DAKO DENMARK A/S·Product code NYQ·January 16, 2014

    HER2 CISH PHARMDEX KIT

    FDA Adverse Event
    Malfunction ·DAKO DENMARK A/S·Product code NYQ·January 16, 2014

    HER2 CISM PHARMDX KIT

    FDA Adverse Event
    Malfunction ·DAKO DENMARK A/S·Product code NYQ·January 16, 2014

    HER2 CISM PHARMDX KIT

    FDA Adverse Event
    Malfunction ·DAKO DENMARK A/S·Product code NYQ·January 16, 2014

    HER2 CISH PHARMDX KIT

    FDA Adverse Event
    Malfunction ·DAKO DENMARK A/S·Product code NYQ·January 16, 2014

    HER2 CISH PHARMDX KIT

    FDA Adverse Event
    Malfunction ·DAKO DENMARK A/S·Product code NYQ·January 16, 2014

    HER2 CISH PHARMDX KIT

    FDA Adverse Event
    Malfunction ·DAKO DENMARK A/S·Product code NYQ·January 16, 2014

    HER2 DUAL ISH

    FDA Adverse Event
    Injury ·VENTANA MEDICAL SYSTEMS, INC·Product code NYQ·January 14, 2016

    HER2 CISH PHARMD KIT

    FDA Adverse Event
    DAKO DENMARK A/S·Product code NYQ·May 23, 2016

    HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code NYQ·May 13, 2013

    Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

    FDA Recall
    Terminated ·Cell Marque Corporation·Product code NYQ·May 5, 2017

    Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - Analyte Specific Reagent

    FDA Recall
    Terminated ·Cell Marque Corporation·Product code NYQ·May 5, 2017

    SPOT-Light" HER2 CISH Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Invitrogen Corporation 7335 Executive Way Frederick MD 21704 www.invitrogen.com*** Product Usage: The SPOT-Light HER2 CISH Kit is intended to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast carcinoma tissue sections and is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered.

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code NYQ·November 14, 2011

    Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2 CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.

    FDA Recall
    Terminated ·Dako North America Inc.·Product code NYQ·January 21, 2014

    Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2 CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.

    FDA Recall
    Terminated ·Dako North America Inc.·Product code NYQ·June 10, 2016

    Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

    FDA classification
    FDA Class 3 ·Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

    Yingtai

    FDA UDI
    Changsha Yingtai Instrument Co., Ltd·06976301910338·Incubator is a temperature-controlled device sp...

    NYES Trinity

    FDA UDI
    New York Embroidery Studio Inc.·00860008955142·Disposable Isolation Gown, AAMI Level 2, XLarge...

    NYES Trinity

    FDA UDI
    New York Embroidery Studio Inc.·00860008955104·Disposable Isolation Gown, AAMI Level 2, Large

    NYES Protect4

    FDA UDI
    New York Embroidery Studio Inc.·00860008955128·Disposable Isolation Gown, AAMI Level 2, Large ...