IVD supports the visualization of the DNP-labeled probe sequence in situ hybridization - Vietnam Registration 230000611/PCBA-HCM
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Device Details
Registration Details
230000611/PCBA-HCM
000.00.19.H29-230523-0005
ultraView SISH DNP Detection Kit
05907136001
Technical Details
The ultraView SISH DNP Detection Kit of Ventana Medical Systems Inc. (Ventana) is an indirect system, without biotin, for the detection of DNP-labeled probes. The kit is used to determine the targets by in situ hybridization (ISH) of silver-labeled probes on formalin-fixed, paraffin-embedded tissue sections on the BenchMark IHC/ISH instrument. The interpretation of the test results based on the coloration or non-coloration must be combined with histological evaluation and the assessment of appropriate tissue control samples (positive and negative controls). The evaluation of the results must be performed by a qualified interpreter, in combination with the patient's clinical history and other diagnostic tests. This detection kit is intended for in vitro diagnostic use (IVD).
Dates and Status
May 24, 2023