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

FDA product code NYQ · Class 3 · Unknown

3
Registered devices
9
Adverse events
6
Recalls
0
510(k) clearances

Devices with this code

HER2 CISH pharmDx™ Kit — AGILENT TECHNOLOGIES SINGAPORE PTE LTDVENTANA HER2 Dual ISH DNA Probe Cocktail — Ventana Medical Systems, Inc.INFORM HER2 Dual ISH DNA Probe Cocktail — Ventana Medical Systems, Inc.

Recent recalls

DateFirmReason
2017-05-05Cell Marque CorporationCell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Ex
2017-05-05Cell Marque CorporationCell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Ex
2016-06-10Dako North America Inc.An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. This has resulted in the HER2 probe concentration be
2014-01-21Dako North America Inc.Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.
2013-05-13Life Technologies CorporationFirm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.
2011-11-14Life Technologies CorporationIn vitro diagnostic reagent may be contaminated with a fungal contaminant.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.