Atlas FDA

LFY

17 FDA 510(k) clearances · Product code

139 daysmedian time to decision
535 days90th percentile
17clearances measured

FDA profile

Official device name
Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3900
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2015: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (K231214)DiaSorin, Inc.2023-10-27
LIAISON VZV IgG, LIAISON Control VZV IgG (K150375)DiaSorin, Inc.2015-03-11
ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM (K070317)Zeus Scientific, Inc.2007-07-05
DIASORIN LIAISON VZV IGG (K061820)DiaSorin, Inc.2007-02-26
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. (K051484)Zeus Scientific, Inc.2005-12-05
THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM (K984181)Zeus Scientific, Inc.1999-01-22
IS-VZU IGG TEST SYSTEM (K981867)Diamedix Corp.1998-09-28
SERAQUEST VZV IGG (K972295)Quest Intl., Inc.1997-11-05
VZV IGG ELISA TEST SYSTEM (K961012)Zeus Scientific, Inc.1996-07-24
VARICELISA, MODIFICATION (K943843)Biowhittaker Molecular Applications, Inc.1996-03-14
VZV IGG ELISA TEST (K941046)Gull Laboratories, Inc.1995-08-24
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (K923122)Biomerieux Vitek, Inc.1992-10-26
SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS (K914022)Pharmacia Diagnostics, Inc.1992-01-27
VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT (K900688)Clinical Sciences, Inc.1990-05-15
VZV MICROASSAY (K890642)Diamedix Corp.1989-05-15
VZV BIO-ENZABEAD SCREEN KIT (K833637)Bionetic Laboratory Products1984-02-10
VARICELISA TEST KIT (K823805)M.A. Bioproducts1983-05-05

Track LFY automatically

Every clearance here is in the API, with alerts when new ones post.