LFY · Class II · 21 CFR 866.3900

FDA Product Code LFY: Enzyme Linked Immunoabsorbent Assay, Varicella-zoster

Leading manufacturers include Zeus Scientific, Inc., DiaSorin, Inc. and Diamedix Corp..

17
Total
17
Cleared
181d
Avg days
1983
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Enzyme Linked Immunoabsorbent Assay, Varicella-zoster Devices (Product Code LFY)

17 devices
1–17 of 17
Cleared Oct 27, 2023
LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
K231214
DiaSorin, Inc.
Microbiology · 182d
Cleared Mar 11, 2015
LIAISON VZV IgG, LIAISON Control VZV IgG
K150375
DiaSorin, Inc.
Microbiology · 26d
Cleared Jul 05, 2007
ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM
K070317
Zeus Scientific, Inc.
Microbiology · 153d
Cleared Feb 26, 2007
DIASORIN LIAISON VZV IGG
K061820
DiaSorin, Inc.
Microbiology · 243d
Cleared Dec 05, 2005
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.
K051484
Zeus Scientific, Inc.
Microbiology · 182d
Cleared Jan 22, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM
K984181
Zeus Scientific, Inc.
Microbiology · 60d
Cleared Sep 28, 1998
IS-VZU IGG TEST SYSTEM
K981867
Diamedix Corp.
Microbiology · 123d
Cleared Jul 24, 1996
VZV IGG ELISA TEST SYSTEM
K961012
Zeus Scientific, Inc.
Microbiology · 133d
Cleared Aug 24, 1995
VZV IGG ELISA TEST
K941046
Gull Laboratories, Inc.
Microbiology · 535d
Cleared Oct 26, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K923122
Biomerieux Vitek, Inc.
Microbiology · 122d
Cleared May 15, 1989
VZV MICROASSAY
K890642
Diamedix Corp.
Microbiology · 96d

About Product Code LFY - Regulatory Context

510(k) Submission Activity

17 total 510(k) submissions under product code LFY since 1983, with 17 receiving FDA clearance (average review time: 181 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.