This facility is provided to enable any interested parties to search for Registered Medical Device, Registered CAB, Licensed Establishments under Section 5, 10, 15 of Medical Device Act 2012 (Act 737) respectively and Notified Medical Device under Medical Device (Exemption) Order 2016. Any party who wishes to know whether an establishment who is dealing with medical device has been licensed under Act 737 may search the establishment by inserting the establishment name or license number in the searching field below.


DEVICE DETAILS

NAME OF DEVICEDAKO PRIMARY ANTIBODIES (KIDNEY AND URINARY TRACT)
ESTABLISHMENT NAMEBITA LIFESCIENCE SDN. BHD.
REGISTRATION NOIVDC17498297018
BRAND NAMEDAKO
DEVICE GROUPING TYPESYSTEM
DEVICE DESCRIPTIONPRIMARY ANTIBODIES ARE INTENDED FOR USE ON TISSUE SECTIONS.
DEVICE INTENDED PURPOSEFOR IN VITRO DIAGNOSTIC USE. THE CLINICAL INTERPRETATION OF ANY STAINING OR ITS ABSENCE SHOULD BE COMPLEMENTED BY MORPHOLOGICAL STUDIES USING PROPER CONTROLS AND SHOULD BE EVALUATED WITHIN THE CONTEXT OF THE PATIENT'S CLINICAL HISTORY AND OTHER DIAGNOSTIC TESTS BY A QUALIFIED PATHOLOGIST.
VALIDITY DATE OF REGISTRATION26/09/2018 - 25/09/2023

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1FLEX Monoclonal Mouse Anti-Human Vimentin, Clone V9, Ready-to-Use (Link)IR630
2FLEX Monoclonal Mouse Anti-Vimentin, Clone V9, Ready-to-Use (Dako Omnis)GA630
3 FLEX Monoclonal Mouse Anti-Human Smooth Muscle Actin, Clone 1A4, Ready-to-Use (Dako Autostainer/Autostainer Plus)IS611
4FLEX Monoclonal Mouse Anti-Human Smooth Muscle Actin, Clone 1A4, Ready-to-Use (Link)IR611
5Monoclonal Mouse Anti-Human Smooth Muscle Actin, Clone 1A4M0851
6FLEX Polyclonal Rabbit Anti-S100, Ready-to-Use (Dako Autostainer/Autostainer Plus)IS504
7FLEX Polyclonal Rabbit Anti-S100, Ready-to-Use (Link)IR504
8FLEX Polyclonal Rabbit Anti-S100, Ready-to-Use (Dako Omnis)GA504
9FLEX Monoclonal Mouse Anti-Human Renal Cell Carcinoma Marker, Clone SPM314, Ready-to-use (Dako Autostainer/Autostainer Plus)IS075
10FLEX Monoclonal Mouse Anti-Human Renal Cell Carcinoma Marker, Clone SPM314, Ready-to-use (link)IR075
11Monoclonal Mouse Anti-Human Renal Cell Carcinoma Marker, Clone SPM314M3632
12FLEX Monoclonal Mouse Anti-Human Ki-67 Antigen, Clone MIB-1, Ready-to-Use (Dako Autostainer/Autostainer Plus)IS626
13FLEX Monoclonal Mouse Anti-Human Ki-67 Antigen, Clone MIB-1, Ready-to-Use (Link)IR626
14FLEX Monoclonal Mouse Anti-Human Ki-67 Antigen, Clone MIB-1, Ready-to-Use (Dako Omnis)GA626
15FLEX Monoclonal Mouse Anti-Vimentin, Clone V9, Ready-to-Use (Dako Autostainer/Autostainer Plus)IS630