ClearanceBrief
Panels › Microbiology › Product code LFY · Class 2

Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster

Regulation 866.3900

0510(k)s in 12 months (17 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
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Top companies in LFY

Decided510(k)Device and applicantCode
Oct 27, 2023K231214LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
DiaSorin, Inc.
LFY
Mar 11, 2015K150375LIAISON VZV IgG, LIAISON Control VZV IgG
DiaSorin, Inc.
LFY
Jul 5, 2007K070317ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM
Zeus Scientific, Inc.
LFY
Feb 26, 2007K061820DIASORIN LIAISON VZV IGG
DiaSorin, Inc.
LFY
Dec 5, 2005K051484ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.
Zeus Scientific, Inc.
LFY
Jan 22, 1999K984181THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM
Zeus Scientific, Inc.
LFY
Sep 28, 1998K981867IS-VZU IGG TEST SYSTEM
Diamedix Corp.
LFY
Nov 5, 1997K972295SERAQUEST VZV IGG
Quest Intl., Inc.
LFY
Jul 24, 1996K961012VZV IGG ELISA TEST SYSTEM
Zeus Scientific, Inc.
LFY
Mar 14, 1996K943843VARICELISA, MODIFICATION
Biowhittaker Molecular Applications, Inc.
LFY
Aug 24, 1995K941046VZV IGG ELISA TEST
Gull Laboratories, Inc.
LFY
Oct 26, 1992K923122VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
Biomerieux Vitek, Inc.
LFY
Jan 27, 1992K914022SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS
Pharmacia Diagnostics, Inc.
LFY
May 15, 1990K900688VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT
Clinical Sciences, Inc.
LFY
May 15, 1989K890642VZV MICROASSAY
Diamedix Corp.
LFY
Feb 10, 1984K833637VZV BIO-ENZABEAD SCREEN KIT
Bionetic Laboratory Products
LFY
May 5, 1983K823805VARICELISA TEST KIT
M.A. Bioproducts
LFY

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