FDA.reportPublic FDA data

Zhenya Volkova

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96102403002808212Zhenya Volkova1N2027-01-011951 Northwestern Ave Stillwater MN US 55082
30124496453012449645Zhenya Volkova1N2027-01-011951 Northwestern Avenue Stillwater MN US 55082

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
208621055984160P990045DIASORIN ETI-AB-COREK PLUS ASSAY2001-03-30
208621966151722P990044DIASORIN ETI-CORE-IGMK PLUS ASSAY2001-03-30
208622040479560P990043DIASORIN ETI-EBK PLUS ASSAYLOM2001-02-08
208621251343934P990042DIASORIN ETI-AB-AUK PLUS ASSAY2001-03-30
208621823605106P990041DIASORIN ETI-AB-EBK PLUS ASSAY2001-03-30
208621811209533P990038DIASORIN ETI MAK-2 PLUS ASSAYLOM2001-03-30
208621360371867P970055BIOTRIN PARVOVIRUS IGM EIA (V619IMUS)MYM1999-08-06
208621630809081P970054BIOTRIN PARVOVIRUS B19 IGGMYL1999-08-06
208621682233420P890019AB -HAVKLOL1990-07-13
208621423904840P890014HA-IGMK AND ETI-HA-IGMKLOL1990-07-24
208621509363038P250039LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM PlusMYM2026-05-07
208621940618408P220034LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG PlusMYL2024-03-29
208621922074656P190017LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory TestLOM2020-08-29
208621172302606P190011LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV AbMZO2019-10-18
208621951286005P180049LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBeSEI2020-08-29
208621796784942P180048LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAgLOM2020-08-29
208621701772719P180047LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON SoftwareNCD2019-11-26
208621068881130P180045LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgMSEI2020-08-29
208621204890495P180039LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs VerifiersSEI2020-02-21
208621314302939P180038LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBcSEI2020-01-02
208621994227741K231214LIAISON VZV IgG HT, LIAISON Control VZV IgG HTLFY2023-10-27
208621238406707K193650LIAISON FerritinDBF2021-09-14
208621718953468K193532LIAISON Anti-HAV AssayLOL2020-03-02
208621679333578K173683LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN VerifiersPRI2018-02-27
208621101981729K162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetLFZ2017-01-06
208621759968133K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control SetLSE2017-01-05
208621685561447K162959LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetLSE2017-01-04
208621867009727K161526LIAISON CMV IgM Serum Control SetJJX2016-06-30
208621989187459K161522LIAISON EBV IgM Serum Control SetJJX2016-06-30
208621890144761K160650LIAISON HAV IgM, LIAISON Control HAV IgMLOL2016-08-25
208621900704888K150375LIAISON VZV IgG, LIAISON Control VZV IgGLFY2015-03-11
208621727219480K141116LIAISON XL ANALYZERLOL2014-07-25
208621568175894K132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IILGD2013-08-28
208621066155279K131441LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM IILGD2013-08-09
208621775998949K131037LIAISON XL HCGDHA2013-09-06
208621663708361K130469LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3JLW2013-04-05
208621621288630K122397LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGMLFX2012-09-06
208621385710348K121951LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3CEC2013-04-04
208621721338574K121944LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENTCIB2013-01-01
208621173354803K112725LIAISON 25 OH VITAMIN D TOTAL ASSAYMRG2012-01-20
208621185625522K103529LIAISON XL ANALYZER MODEL 10050LOL2011-01-21
208621295789894K1023143M INTEGRATED CYCLER (110V) & (220V)OOI2010-10-29
2833481295789894K1023143M INTEGRATED CYCLER (110V) & (220V)OOI2010-10-29
208621340560358K082050LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGMLOL2008-11-03
208621801889190K082049LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAVLOL2008-12-05
208621061492371K073390DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLSLFX2008-11-21
208621649892707K061820DIASORIN LIAISON VZV IGGLFY2007-02-26
208621796036534K061247DIASORIN LIAISON TREPONEMA ASSAYLIP2006-07-31
208621844247620K060204LIAISON EA IGGLSE2006-10-18
208621327890478K052794ETI-MAX 3000JJF2006-03-31
208621161359012K040290DIASORIN LIAISON CMV IGM/IGGLFZ2005-06-01
208622030024880K040120DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYSLLM2005-04-29
208621864838728DEN250032LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)SGW2025-12-23
208621893148278BK241116
208621041000096
208621045112315
208621058627610
208621138875918
208621410361514
208621482762109
208621576412905
208621710439737
208621745715251
208621763856113
208621769606019
208621801195120
208621828606535
208621888530683
208621888805178

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOM 62020-08-29
LOL62020-03-02
LFY32023-10-27
LSE32017-01-05
LOM32001-03-30
LFZ22017-01-06
JJX22016-06-30
LGD22013-08-28
LFX22012-09-06
OOI22010-10-29
SGW12025-12-23
DBF12021-09-14
NCD12019-11-26
PRI12018-02-27
DHA12013-09-06
JLW12013-04-05
CEC12013-04-04
CIB12013-01-01
MRG12012-01-20
LIP12006-07-31
JJF12006-03-31
LLM12005-04-29
MYM11999-08-06
MYL11999-08-06