Singapore - English - HSA (Health Sciences Authority)

beckman coulter singapore pte. ltd. - immunology - cyto-stat tetrachrome cd45-fitc/cd4-rd1/cd8-ecd/cd3-pc5 and cyto-stat tetrachrome cd45-fitc/cd56-rd1/cd19-ecd/cd3-pc5 monoclonal antibody reagents are for use on the coulter epics xl/xl-mcl, cytomics fc 500 and navios flow cytometers. the reagents are also used with the tetraone system for coulter epics xl/xl-mcl flow cytometer, the tetracxp system for fc 500 flow cytometry system and navios tetra software for the navios system. used alone or in combination with the automated systems, the reagents are intended "for in vitro diagnostic use" and allow simultaneous identification and enumeration of total cd3+, total cd4+, total cd8+, dual cd3+cd4+, dual cd3+cd8+ and/or total cd3+, cd19+ and cd3-cd56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. the systems also provide the cd4/cd8 ratio when using cd45-fitc/cd4-rd1/ cd8-ecd/cd3-pc5.

Singapore - English - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - hematology - it is the monoclonal igm antibodies reagents for the rh system.

Singapore - English - HSA (Health Sciences Authority)

leica microsystems (sea) pte ltd - microbiology - it is for in vitro diagnostic use for the qualitative identification by light microscopy of helicobacter pylori molecules in paraffin sections. 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct1056 - immunohistology cell marker ivds - immunohistochemical staining of tissues for alk protein as an aid in identifying patients eligible for treatment with nominated therapies in selected indications intended for qualitative detection of the anaplastic lymphoma kinase (alk) protein in formalin-fixed, paraffin-embedded non-small cell lung carcinoma (nsclc) tissue.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct1056 - immunohistology cell marker ivds - immunohistochemical staining of tissues for her-2 antigen as an aid in identifying patients eligible for treatment with nominated therapies in selected indications. ventana her2 (4b5) rabbit monoclonal primary antibody rxdx is intended for the semi-quantitative detection of her2 antigen by immunohistochemistry (ihc) in sections of formalin-fixed, paraffin-embedded breast and gastric tissue stained on a benchmark ihc/ish instrument. this ihc device is indicated for identifying breast cancer patients who are eligible for treatment with trastuzumab, pertuzumab, trastuzumab emtansine, or famtrastuzumab deruxtecan-nxki. additionally, this ihc device is indicated as an aid in the assessment of gastric cancer patients for whom trastuzumab treatment is being considered.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct1056 - immunohistology cell marker ivds - immunohistochemical staining of tissues for mmr status as an aid in identifying patients eligible for treatment with nominated therapies in selected indications ventana anti-mlh1 (m1) mouse monoclonal primary antibody is intended for use in the assessment of mismatch repair (mmr) protein mlh1 in formalin-fixed, paraffin-embedded tissue specimens stained on a ventana benchmark ultra and benchmark ultra plus instrument. this antibody is one of the components of ventana mmr rxdx panel that is indicated as an aid in identifying patients eligible for treatment with pembrolizumab in deficient mmr solid tumours, and a combination of pembrolizumab and lenvatinib in proficient mmr endometrial carcinoma.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct1056 - immunohistology cell marker ivds - immunohistochemical staining of tissues for mmr status asan aid in identifying patients eligible for treatment withnominated therapies in selected indications ventana anti-msh2 (g219-1129) mouse monoclonal primary antibody is intended for use in the assessment of mismatch repair (mmr) protein msh2 in formalin-fixed, paraffin-embedded tissue specimens stained on a ventana benchmark ultra and benchmark ultra plus instrument. this antibody is one of the components of ventana mmr rxdx panel that is indicated as an aid in identifying patients eligible for treatment with pembrolizumab in deficient mmr solid tumours, and a combination of pembrolizumab and lenvatinib in proficient mmr endometrial carcinoma.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct1056 - immunohistology cell marker ivds - immunohistochemical staining of tissues for mmr status as an aid in identifying patients eligible for treatment with nominated therapies in selected indications ventana anti-msh6 (sp93) rabbit monoclonal primary antibody is intended for use in the assessment of mismatch repair (mmr) protein msh6 in formalin-fixed, paraffin-embedded tissue specimens stained on a ventana benchmark ultra and benchmark ultra plus instrument. this antibody is one of the components of ventana mmr rxdx panel that is indicated as an aid in identifying patients eligible for treatment with pembrolizumab in deficient mmr solid tumours, and a combination of pembrolizumab and lenvatinib in proficient mmr endometrial carcinoma.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct1056 - immunohistology cell marker ivds - immunohistochemical staining of tissues for mmr status as an aid in identifying patients eligible for treatment with nominated therapies in selected indications ventana anti-pms2 (a16-4) mouse monoclonal primary antibody is intended for use in the assessment of mismatch repair (mmr) protein pms2 in formalin-fixed, paraffin-embedded tissue specimens stained on a ventana benchmark ultra and benchmark ultra plus instrument. this antibody is one of the components of ventana mmr rxdx panel that is indicated as an aid in identifying patients eligible for treatment with pembrolizumab in deficient mmr solid tumours, and a combination of pembrolizumab and lenvatinib in proficient mmr endometrial carcinoma.

European Union - English - EMA (European Medicines Agency)

neovii biotech gmbh - catumaxomab - ascites; cancer - other antineoplastic agents - removab is indicated for the intraperitoneal treatment of malignant ascites in patients with epcam-positive carcinomas where standard therapy is not available or no longer feasible.,