SGW

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Device To Detect Antibodies To Hepatitis D Virus

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3176

Medical specialty

Immunology

FDA 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.

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