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DiaSorin, Inc.

FDA 510(k) & PMA Approved Devices — 41 products

Total Devices41
Categories20
Latest FDA decision2026-06-24
TypeNumberDevice NameCodeDateActions
PMA P220034 ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGGMYL2026-06-24 View
PMA P250039 ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGMMYM2026-06-24 View
510(k) K260770 LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXLOM2026-06-04 View
PMA P180047 TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSISNCD2026-05-26 View
PMA P180048 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-10-10 View
PMA P180049 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-10-10 View
PMA P180045 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-10-10 View
PMA P190017 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-10-10 View
PMA P180038 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-10-10 View
PMA P180039 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-10-10 View
510(k) K231214 LIAISON VZV IgG HT, LIAISON Control VZV IgG HTLFY2023-10-27 View
510(k) K223403 LIAISON Anti-HAV; LIAISON XSLOL2022-12-09 View
510(k) K213858 LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusNXO2022-07-26 View
510(k) K213936 LIAISON MeMed BV, LIAISON MeMed BV Control SetQPS2022-07-14 View
PMA P990042 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2021-12-21 View
PMA P990044 Unknown Device2021-12-21 View
PMA P990043 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2021-12-21 View
PMA P990045 Unknown Device2021-12-21 View
PMA P990041 Unknown Device2021-12-21 View
PMA P990038 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2021-12-21 View

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