FDA Product Code SGW: Device To Detect Antibodies To Hepatitis D Virus
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.
Leading manufacturers include DiaSorin, Inc..
List of Device To Detect Antibodies To Hepatitis D Virus devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Device To Detect Antibodies To Hepatitis D Virus devices (product code SGW). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →