Roche Diagnostics Elecsys HBsAg Confirm

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

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Available from:

Roche Diagnostics Asia Pacific Pte Ltd

Class:

Class D IVD

Manufactured by:

Roche Diagnostics GmbH

Therapeutic area:

Immunology

Therapeutic indications:

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.

Product summary:

Models: Elecsys HBsAg II Auto Confirm - 08741034190, PreciControl HBsAg II - 04687876190, PreciControl HBsAg II Auto Confirm - 08741107190, Elecsys HBsAg Confirmatory Test - 09127127190

Authorization date:

2021-07-02

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