510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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DEN250032Unknown

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

Diasorin Inc., Stillwater MN / Direct, Unknown
FDA source (opens on fda.gov)

DEN250032 is the FDA 510(k) clearance record for LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261), a class II device, cleared for DiaSorin, Inc. on under FDA product code SGW (Device To Detect Antibodies To Hepatitis D Virus). FDA's definition for product code SGW reads: "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...". FDA records list 74 510(k) clearances for DiaSorin, Inc., from to . As of , FDA records show no recalls naming DEN250032.

Clearance record

Decision date
Received
(146 days to decision)
Product code
SGW Device To Detect Antibodies To Hepatitis D Virus
Regulation
21 CFR 866.3176
Device class
Class II
Review panel
Immunology
Applicant
DiaSorin, Inc. 1951 Northwestern Ave., Stillwater MN
Third party review
No

Clearances, product code SGW

Trailing 12 months
1 clearance under product code SGW in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SGW, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260