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Vitamin B12 Injection is an injectable cyanocobalamin product used to treat or prevent low vitamin B12 levels when replacement by mouth may not be enough

In Pernicious Anaemia, a lack of intrinsic factor leads to B12 not being absorbed properly regardless of dietary intakeleading to deficiency

In 2014, the FDA granted AOD 9604 Human GRAS (Generally Recognized As Safe) status, indicating a favorable safety profile when used as directed

The applicant is only seeking a new device category for transitional pass-through payment status for the LithoVue TM Elite Ureteroscope, a component of the LithoVue TM Elite System

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