Singapura - Inggris - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - immunoassay for in vitro confirmation of the presence of hepatitis b surface antigen in human serum and plasma samples repeatedly reactive when tested with the elecsys hbsag ii assay. the electrochemiluminescence immunoassay “eclia” is intended for use on cobas e immunoassay analyzers.

Singapura - Inggris - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - immunoassay for the in vitro quantitative determination of procalcitonin (pct) in human serum and plasma. pct is a marker of host response to bacterial infection. the elecsys brahms pct assay is indicated as an aid to be used in conjunction with clinical evaluation for: ▪ the early detection of clinically relevant bacterial infections ▪ the assessment of the degree of severity and the prognosis of the outcome of systemic bacterial infection, sepsis, and septic shock ▪ identifying patients that benefit from antibiotic treatment ▪ monitoring of antibiotic therapy ▪ assessing the success of antibiotic therapy in patients with suspected or confirmed bacterial infection. the electrochemiluminescence immunoassay “eclia” is intended for use on cobas e immunoassay analyzers.

Singapura - Inggris - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - the elecsys phospho-tau (181p) csf assay is an in vitro diagnostic immunoassay intended for the quantitative determination of the phosphorylated tau protein in human csf. 1. the elecsys phospho‑tau (181p) csf assay is intended to be used alone or in combination with elecsys β‑amyloid (1‑42) csf ii assay as a ratio in adult subjects with mild cognitive impairment (mci) as an aid to identify subjects who are at lower vs. higher risk of cognitive decline as defined by change in a clinical score within a 2 year period. 2. the elecsys phospho‑tau (181p) csf assay is intended to be used in combination with elecsys β‑amyloid (1‑42) csf ii assay as a ratio in adult subjects with cognitive impairment being evaluated for ad and other causes of cognitive impairment wherein a positive and negative csf result is concordant with positive and negative amyloid positron emission tomography (pet) scan result, respectively.

Singapura - Inggris - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - the elecsys total‑tau csf assay is an in vitro diagnostic immunoassay intended for the quantitative determination of the total tau protein in human csf. 1. the elecsys total‑tau csf assay is intended to be used alone or in combination with elecsys β‑amyloid (1‑42) csf ii assay as a ratio in adult subjects with mild cognitive impairment (mci) as an aid to identify subjects who are at lower vs. higher risk of cognitive decline as defined by change in a clinical score within a 2 year period. 2. the elecsys total‑tau csf assay is intended to be used in combination with elecsys β‑amyloid (1‑42) csf ii assay as a ratio in adult subjects with cognitive impairment being evaluated for ad and other causes of cognitive impairment wherein a positive and negative csf result is concordant with positive and negative amyloid positron emission tomography (pet) scan result, respectively.

Singapura - Inggris - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - quantitative determination of β‑amyloid (1‑42) in csf. 1. for use in adult subjects with cognitive impairment (ci) being evaluated for alzheimer disease (ad) and other causes of ci. result above the cutoff is consistent with a negative amyloid pet scan. negative scans indicate sparse to no neuritic plaques and are inconsistent with a neuropathological diagnosis of ad at the time of image acquisition. 2. for use in combination with elecsys phospho‑tau or total‑tau csf assay in adult subjects with ci being evaluated for ad and other causes of ci wherein a positive and negative csf result are concordant with positive and negative amyloid pet scan result, respectively. 3. for use alone or in combination with elecsys phospho‑tau or total‑tau csf assay in adult subjects with mild ci as an aid to identify subjects who are at lower vs. higher risk of cognitive decline as defined by change in a clinical score within a 2 year period.

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

roche diagnostics australia pty limited -

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

roche diagnostics australia pty limited -

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

roche diagnostics australia pty limited - 48331 - hepatitis b virus e-antigen ivd, kit, chemiluminescent immunoassay - an electrochemiluminescence immunoassay "eclia" intended for use for use on the cobas e 402 and cobas e 801 analysers enabling in vitro qualitative and quantitative detection of hbeag for diagnosis and monitoring in a single test. immunoassay for the in vitro qualitative and quantitative determination of hepatitis b e antigen (hbeag) in human serum and plasma. the assay can be used as an aid for the diagnosis and monitoring of patients with hepatitis b viral infection. the electrochemiluminescence immunoassay ?eclia? is intended for use on cobas e immunoassay analyzers.

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

roche diagnostics australia pty limited - 48331 - hepatitis b virus e-antigen ivd, kit, chemiluminescent immunoassay - an electrochemiluminescence immunoassay "eclia" intended for use for use on the cobas e 411, cobas e 601 and cobas e 602 analysers enabling in vitro qualitative and quantitative detection of hbeag for diagnosis and monitoring in a single test. immunoassay for the in vitro qualitative and quantitative determination of hepatitis b e antigen (hbeag) in human serum and plasma. the assay can be used as an aid for the diagnosis and monitoring of patients with hepatitis b viral infection. the electrochemiluminescence immunoassay ?eclia? is intended for use on cobas e immunoassay analyzers.

Singapura - Inggris - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - immunoassay for the in vitro qualitative determination of total antibodies to treponema pallidum in human serum and plasma. the test is intended as an aid in the diagnosis of syphilis infection. the electrochemiluminescence immunoassay “eclia” is intended for use on cobas e immunoassay analyzers. the performance has been established for diagnostic use and for screening of blood donations and for use of cadaveric blood specimens(plasma only).