Ortho-Clinical ECI Immunodiagnostic Products HBsAg Controls

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

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Available from:

ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.

Class:

Class D IVD

Manufactured by:

Ortho-Clinical Diagnostics

Therapeutic area:

Immunology

Therapeutic indications:

For use in monitoring the performance of the VITROS Analyzers when used for the qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (EDTA, heparin or citrate). The performance of the VITROS Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assays.

Product summary:

Models: HBsAg Controls - 6800598

Authorization date:

2006-01-05

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