Vietnam MOH registration 230000611/PCBA-HCM

IVD supports the visualization of the DNP-labeled probe sequence in situ hybridization

VN: IVD hỗ trợ hiện màu đoạn dò đã đánh dấu DNP trong lai tại chỗ

Vietnam·Risk Class TTBYT Loại A·ultraView SISH DNP Detection Kit·Ventana Medical Systems, Inc.·Registered May 24, 2023

Registration details

Analysis ID: 230000611/PCBA-HCM
Submission ID: 000.00.19.H29-230523-0005
Product Type: ultraView SISH DNP Detection Kit
Product Code: 05907136001

Company information

Manufacturer: Ventana Medical Systems, Inc.
Manufacturer Country: UNITED STATES

Technical details

Intended Use: 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

Registration Date: May 24, 2023

About this record

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