Product code LJO— Microbiology

FDA has cleared 12 devices under product code LJO between 1983 and 2021, filed by 10 applicant companies. 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.

• 20211 clearance
• 20191 clearance
• 20001 clearance
• 19982 clearances
• 19962 clearances
• 19921 clearance
• 19911 clearance
• 19851 clearance
• 19841 clearance
• 19831 clearance

• Immucor, Inc.3 clearances
• Sienna Biotech, Inc.1 clearance
• Instrumentation Laboratory CO1 clearance
• Hillcrest Biologicals1 clearance
• E.I. Dupont DE Nemours & Co., Inc.1 clearance
• Digene Corp.1 clearance
• Diamedix Corp.1 clearance
• Cetus Corp.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance
• Akers Research Corp.1 clearance

• K203612 — Capture-CMVImmucor, Inc.·2021-03-22
• K183571 — Capture-CMVImmucor, Inc.·2019-02-04
• K001767 — DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEMDiamedix Corp.·2000-08-07
• K974901 — HYBRID CAPTURE SYSTEM CMV DNA ASSAYDigene Corp.·1998-09-29
• K974456 — CMVGENInstrumentation Laboratory CO·1998-05-01
• K951851 — ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYE.I. Dupont DE Nemours & Co., Inc.·1996-07-24
• K955799 — COPALIS CMV TOTAL ANTIBODY ASSAYSienna Biotech, Inc.·1996-07-10
• K920222 — HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUSAkers Research Corp.·1992-07-27
• K910003 — CYTOMEGALOVIRUS ANTIBODY SCREENImmucor, Inc.·1991-03-20
• K852494 — CMV-IHAHillcrest Biologicals·1985-09-16
• K841520 — CMV LATEX AGGLUTINATION TEST KITBd Becton Dickinson Vacutainer Systems Preanalytic·1984-09-07
• K822965 — CETUS CMV IHACetus Corp.·1983-02-15