DeviceClearance

Product code SGW— Immunology

LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)

Classification name
Device To Detect Antibodies To Hepatitis D Virus
Device class
Class 2
Regulation
21 CFR 866.3176
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SGW under 21 CFR 866.3176, via openFDA

Market context for product code SGW

FDA has cleared 1 device under product code SGW, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SGW

Recent clearances under product code SGW

Data sourced from openFDA. This site is unofficial and independent of the FDA.