IMMULITEIMMULITE 1000 CMV IgM and IMMULITE CMV IgM Controls

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

SIEMENS HEALTHCARE PTE. LTD.

Class:

Class C IVD

Manufactured by:

Siemens Healthcare Diagnostics Products Limited

Therapeutic area:

Microbiology

Therapeutic indications:

IMMULITE/IMMULITE 1000 CMV IgM is for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers – for the qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum or plasma (EDTA and heparinized), as an aid in the determination of an acute CMV infection. CMV IgM controls are assayed, bi-level controls intended for use with the IMMULITE/IMMULITE 1000, IMMULITE 2000 and IMMULITE 2500 CMV IgM assays. They are intended as an aid in monitoring day-to-day assay performance.

Product summary:

Models: IMMULITE®/IMMULITE® 1000 CMV IgM - LKCM1, LKCM2, IMMULITE® CMV IgM Controls - LCMC1, LCMC2

Authorization date:

2011-03-01