DevicePMAs@therightstef:P010054_S004 JSON TXT

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.

projects that include this document

Unselected / annnotation		Selected / annnotation
blah6_medical_device 0 (0) PMA_Manual 0 (0) PMA_MER 9 (9) test-2 0 (0) blah6 0 (0) med-device 0 (0) consensus_PMA_Age_Indications 0 (0) age_PMA_annotations 0 (0) Age_blah 0 (0) PMA_age_indications 0 (0) updated_tagging_age_PMA_annotations 0 (0)

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DevicePMAs@therightstef:P010054_S004 JSONTXT

projects that include this document

DevicePMAs@therightstef:P010054_S004 JSON TXT