139061
FDA Guidance Female With Reflex

a. 138749, HBsAg with reflex to confirmatory neutralization assay

b. 138979, HBcore Total with reflex to IgM

c. 138915, HCV with reflex to confirmatory RIBA

d. 138931, HIV-1/HIV-2 plus O with reflex to HIV-1 WB

e. 139280, Syphilis (T. pallidum IgG)

f. 138828, CT/NG NAA

g. 139240, HIV-1/HCV/HBV Ultrio NAT

a. 138874, HBsAg

b. 138699, HBcore Total

c. 138907, HCV

d. 138948, HIV-1/HIV-2 plus O

e. 139280, Syphilis (T. pallidum IgG)

f. 138922, HTLV I/II

g. 138662, CMV Total

h. 138828, CT/NG NAA

i. 139240, HIV-1/HCV/HBV Ultrio NAT

139063
FDA Guidance Male With Reflex

a. 138749, HBsAg with reflex to confirmatory neutralization assay

b. 138979, HBcore Total with reflex to IgM

c. 138915, HCV with reflex to confirmatory RIBA

d. 138931, HIV-1/HIV-2 plus O with reflex to HIV-1 WB

e. 139280, Syphilis (T. pallidum IgG)

f. 138780, HTLV I/II with reflex to Immunoblot

g. 138697, CMV Total with reflex to IgM

h. 138828, CT/NG NAA

i. 139240, HIV-1/HCV/HBV Ultrio NAT