SGW — Device To Detect Antibodies To Hepatitis D Virus Class II
FDA product code SGW covers "Device To Detect Antibodies To Hepatitis D Virus", a Class II medical device regulated under 21 CFR 866.3176. Submissions are reviewed by the Immunology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SGW
- Device Class
- Class II
- Regulation Number
- 866.3176
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Immunology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250032 | diasorin | LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) | December 23, 2025 |