LFZClass II

Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

21 CFR 866.3175 / Microbiology

LFZ is the FDA product code for Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, a class II device type, regulated under 21 CFR 866.3175. As of 2026-09-10, FDA records hold 58 510(k) clearances under this code, the most recent dated 2022-10-27, and 9 recalls.

Classification record

Product code: LFZ
Device name: Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Regulation: 21 CFR 866.3175
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 58
Ingested recalls: 9

Clearances, product code LFZ

By decision year

58 clearances under product code LFZ with a decision year between 1982 and 2022, 1990 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code LFZ by decision year
Year	Clearances
1982	1
1983	3
1985	1
1988	1
1989	8
1990	9
1991	2
1992	5
1993	3
1994	1
1996	7
1997	3
1998	3
1999	3
2005	1
2014	2
2017	2
2018	1
2022	2

Applicants with the most clearances

Product code LFZ

Applicants holding the most 510(k) clearances under product code LFZ
Applicant	Clearances
Abbott Medical	6
Behring Diagnostics, Inc.	5
Zeus Scientific LLC	5
Gull Laboratories, Inc.	4
Roche Diagnostics GmbH	4
Diasorin Inc.	3
Siemens Healthcare Diagnostics Inc.	3
Incstar Corp.	3
Mercia Diagnostics, Ltd.	3
Disease Detection International, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order