SGW · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.3176
Classification
FDA Product Code
SGW
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3176
Review panel
MI
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.