FDA Product Code LFZ: Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Leading manufacturers include Roche Diagnostics and Abbott Laboratories.
58
Total
58
Cleared
198d
Avg days
1982
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Devices (Product Code LFZ)
58 devices
Cleared
Oct 27, 2022
Architect CMV IgG
Abbott Laboratories
Microbiology
209d
Cleared
Oct 12, 2022
Elecsys CMV IgG
Roche Diagnostics
Microbiology
197d
About Product Code LFZ - Regulatory Context
510(k) Submission Activity
58 total 510(k) submissions under product code LFZ since 1982, with 58 receiving FDA clearance (average review time: 198 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
LFZ devices are reviewed by the Microbiology panel. Browse all Microbiology devices →