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..
1
Total
0
Cleared
146d
Avg days
2025
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared Device To Detect Antibodies To Hepatitis D Virus Devices (Product Code SGW)
1 devices
About Product Code SGW - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SGW since 2025, with 0 receiving FDA clearance (average review time: 146 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.