LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX
FDA 510(k) K260770 · DiaSorin, Inc.
510(k) numberK260770
Submission
- Device name
- LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX
- Applicant
- DiaSorin, Inc.
Stillwater, MN, US - Received
- March 9, 2026
- Decision date
- June 4, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LOM – Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3172
- Specialty
- Microbiology
In vitro diagnostic device intended for aid in the diagnosis of chronic or acute HBV infection. HBV surface antigen (HbsAg) is also used for screening of HBV infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during perinatal period.
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Questions and answers
When was LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX cleared by the FDA?
LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX (K260770) received a 510(k) decision of Substantially Equivalent on June 4, 2026, 87 days after the submission was received.
What is the product code of K260770?
The FDA product code is LOM – Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen), a Class II (moderate risk) device regulated under 21 CFR 866.3172.