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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device to detect antibodies to hepatitis d virus
Definition The device to detect antibodies to hepatitis D Virus is an in vitro diagnostic device intended for prescription use for the detection of antibodies to the hepatitis D virus (anti-HDV) in human clinical specimens. The assay is intended as an aid in the diagnosis of HDV infection in individuals who are at risk for HDV infection. The assay is intended as an aid in diagnosis in conjunction with clinical findings and other diagnostic procedures. The assay is not intended for screening of blood, plasma, cells, or tissue donors.
Product CodeSGW
Regulation Number 866.3176
Device Class 2


Premarket Reviews
ManufacturerDecision
DIASORIN, INC.
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