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DevicePMAs@therightstef:P010054_S004 JSONTXT 11 Projects

Approval for a modification to the standardization process for the elecsys anti-hbs immunoassay and elecsys precicontrol anti-hbs assay for use on the elecsys 2010 analyzer. The device, as modified, will be marketed under the trade name elecsys anti-hbs immunoassay and elecsys precicontrol anti-hbs and is indicated for the qualitative detection in human serum and plasma.

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