FDA.reportPublic FDA data

Damon Loya

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96143733002808340Damon Loya1N2026-01-019606 Kearny Villa Rd San Diego CA US 92126

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
143271251045326K992488TOTAL HAEMOLYTIC COMPLEMENT RID KITDAE1999-09-17
143271888668068K982100IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITSCFN1999-12-20
143271516182836K981912HUMAN IGA SUBCLASS BNII COMBI KITCFN1998-12-04
143271285451648K981786IGA MININEPH ANTISERUMCFQ1999-11-24
143271377739364K981785C4 MININEPH ANTISERUMDBI1999-12-20
143271634459319K981784IGM MININEPH ANTISERUMCFN1999-12-21
143272009387773K981783C3 MININEPH ANTISERUMCZW1999-12-20
143271482679632K974111QUIDEL CH50 EQ EIADAE1998-07-29
143271696358230K950383APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KITJHN1995-09-15
143271883225307K950382APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KITJHN1995-09-15
143271958171307K950015HUMAN PROTEIN C RID TEST KITGGP1995-03-06
143271333238867K946069HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KITJZG1996-01-30
143271424292612K946068HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KITJZG1996-01-30
143271167776567K942326HUMAN C5 RID KITSDAY1995-08-24
143271967917429K941346PLASMINOGEN RID TEST KITDDX1994-09-09
143271611114035K940422IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZERDFZ1994-05-27
143272032767548K931806IGA SUBCLASS RID KIT FOR DIAGNOSTIC USECZP1993-07-16
143271817937550K924769IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFICCFF1993-02-23
143271987626170K924767IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFICCFF1993-02-23
143271742670379K924262ENA SCREENING CIE KIT FOR DIAGNOSTIC USELLL1992-12-29
143271693942310K922417AL-ACID GLYCOPROTEIN RID KITLKL1992-08-20
143271349954811K922416FIBRINOGEN RID TEST KITKQJ1993-03-09
143271070406130K915431COMPLEMENT C1 INACTIVATOR KITDBA1992-01-17
143271222808374K914391ALBUMIN TEST RID KITDCF1991-12-10
143271054858792K914390TRANSFERRIN RID KITDDG1991-12-09
143271837065482K914388C1 RID KITDAK1991-10-28
143271616062223K913672PREALBUMIN IMMUNOLOGICAL NL TEST KITJZJ1991-12-20
143271330733796K913671HUMAN IGD IMMUNOLOGICAL NL TEST KITCZJ1991-12-02
143271147381272K913670HAPTOGLOBIN IMMUNOLOGICAL TEST KITDAB1991-12-09
143271093355546K913668CAERULOPLASMIN IMMUNOLOGICAL NL TEST KITDDB1991-12-20
143271491760253K913667ANTITHROMBIN III IMMUNOLOGICAL NL TEST KITJBQ1992-01-03
143271717050566K913666ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KITDEM1991-12-09
143271649897733K905633HUMAN C-REACTIVE PROTEIN RID KITDCK1991-07-22
143271883778239K902382C3C AND C4 RID KITSCZW1990-09-07
143271318573676K881828IMMUNOGLOBULIN M TEST SYSTEMCFQ1988-06-06
143271382020146K881827IMMUNOGLOBULIN A TEST SYSTEMCFQ1988-06-10
143271135375405K875356IMMUNOGLOBULIN G & G SUBCLASSESDEW1988-02-10
143271185499225K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitDFH2025-05-23
143271304712122K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserSGG2025-10-17
143271983177545K231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitDFH2024-01-24
143271546988829K192116Human IgA liquid reagent kit for Use on SPAPlusCFN2019-09-04
143271092403938K191985Optilite IgA KitCFN2019-08-19
143272013065718K191635Optilite IgM KitCFN2019-07-15
143271261684794K191465Human IgM Kit for use on SPAPlusCFN2019-06-27
143271863304790K190686Optilite IgM CSF KitCFN2019-05-28
143271644999523K183151Optilite IgA CSF KitCFN2019-01-23
143271730015935K180099Optilite High Sensitivity C-Reactive Protein KitDCN2018-10-12
143271252840085K173732Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free KitDFH2018-08-23
143271384604531K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsDCN2018-02-28
143271846934416K172613Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda KitPCN2018-02-15
143271648020833K162263Optilite Rheumatoid Factor KitDHR2017-05-03
143271281734701K161982C-Reactive Protein Kit for use on SPAPLUSDCN2017-04-05
143271128858699K161854Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUSPCN2016-10-04
143271651727273K160819Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda KitOPX2016-06-16
143271940160570K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSDHR2016-12-07
143271471822364K153560Optilite Low Level Albumin KitDCF2016-08-25
143271458002373K152389Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda KitPDE2015-12-18
143271578793815K151759Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUSOPX2015-11-06
143271846245479K150658Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free KitDFH2015-08-26
143271745977822K150526Optilite IgG4 KitCFN2015-05-30
143271857418276K150412Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 CalibratorDAE2015-08-28
143271189655148K143118Human Microalbumin kit for use on SPAPLUSDCF2015-05-26
143271889970509K142735The Optilite IgG3 kitCFN2014-12-21
143271558316619K141100OPTILITE C1 INACTIVATOR KITDBA2014-07-18
143271475165992K140686HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUSPDE2014-08-06
143271871511159K140664HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUSDEB2014-04-16
143271913398499K140396FREELITE HUMAN LAMBDA FREE KITDEH2014-04-16
143271344604653K140105HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNIIOPX2014-03-18
143271549863724K132555HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KITPCN2013-12-20
143271324630976K123256HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUSDEM2013-07-03
143271480382952K122965HUMAN CAERULOPLASMIN KITDDB2013-06-03
143271550493380K122304HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUSDBA2013-04-15
143271158704681K122066HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUSJZG2012-08-30
143271074103822K121045HUMAN ALBUMIN CSF KITDCF2013-06-19
143271231017519K120901HUMAN IGA CSF KIT FOR USE ON SPAPLUSCFN2013-05-30
143271422522145K120750HUMAN IGM CSF KITCFN2013-05-17
143271253554178K120749HUMAN IGG CSF KITCFN2013-05-17
143271661433691K120236TRANSFERRIN KIT FOR USE ON THE SPAPLUSDDG2013-02-13
143271999595025K120056HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSERDFH2013-04-01
143271144306365K113823HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KITCFN2013-03-27
143271637238808K113349HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FODAE2012-07-11
143271380685681K103824HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUSCFN2012-02-27
143272053104845K100588HUMAN IGA2 KIT FOR USE ON THE SPAPLUSCFN2010-08-16
143272027054608K100455SPAPLUS ANALYZERDBI2010-09-03
143271391499207K100179SPAPLUSCZW2010-08-13
143271501160966K092450HUMAN IGD KIT FOR USE ON SPAPLUSCZJ2009-12-28
143271209902366K090920HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)CFN2009-12-30
143271398929402K083289HUMAN BETA-2 MICROGLOBULIN KITJZG2009-05-06
143271339122772K082823HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITSCFN2010-03-01
143271876111202K082129HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZERCFN2009-02-10
143271225543825K081827HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUSCFN2008-12-19
143271855791160K080384HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSERNDY2008-06-06
143271184677321K072889HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSERCFN2008-02-01
143271203119694K072166CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZERNDY2008-01-24
143271085837749K070900FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KITDFH2007-11-30
143271604605587K062372FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZERDFH2007-06-21
143271900905513K051915FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZERDFH2005-09-06
143271331176229K051299IGD DIAGNOSTIC TEST KITSCZJ2005-11-23
143271816527450K042152BINDING SITE IGG SUBLCASS OLYMPUS KITSCFN2004-11-22
143271773233944K041891MININEPH HUMAN RHEUMATOID FACTOR KITDHR2004-11-05
143271448731755K040009FREELITE HUMAN KAPPA AND LAMBDA KITSDFH2004-03-11
143271458439225K033811FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZERDEH2004-01-30
143271606951727K031016FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER IIDEH2003-07-15
143271039742201K023131FREELITE HUMAN LAMBDA FREE KITDEH2003-01-21
143271968137011K023009FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZERDFH2003-01-21
143271472522715K022083HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSERCFN2002-07-16
143271521335168K021081HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSERDFZ2002-06-17
143271662235870K014270MININEPH HUMAN B2-MICROGLOBULIN KITJZG2002-08-15
143271887196957K012295HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.TCFN2001-08-20
143271315565991K012292HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TBCFN2001-08-31
143271570245941K011662MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROLDDG2001-07-30
143271799291686K011568RANDOX LIPOPROTEINJIS2001-09-28
143271051549601K010441FREELITE KAPPA FREE KITDEH2001-04-26
143271703244075K010440FREELITE LAMBDA FREE KITDEH2001-04-26
143271952907946K010147ENA EIA KITLLL2001-03-01
143271066357580K003671LAMBDA IMMAGE FREELITE KITDEH2001-02-01
143271879280597K003669KAPPA IMMAGE FREELITE KITDFH2001-02-01
143271197663901K002564SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KITDFH2000-10-26
143271028714378K002563SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KITDEH2000-10-26
143271478173599K002561SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KITCZJ2000-10-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CFN272019-09-04
DFH122025-05-23
DEH82014-04-16
JZG52012-08-30
DCF42016-08-25
DAE42015-08-28
CZJ42009-12-28
DCN32018-10-12
PCN32018-02-15
DHR32017-05-03
OPX32016-06-16
DBA32014-07-18
DDG32013-02-13
CZW32010-08-13
CFQ31999-11-24
PDE22015-12-18
DEM22013-07-03
DDB22013-06-03
DBI22010-09-03
NDY22008-06-06
DFZ22002-06-17
LLL22001-03-01
DCK22000-08-24
JHN21995-09-15
CFF21993-02-23
SGG12025-10-17
DEB12014-04-16
JIS12001-09-28
DGC12000-10-26
DAY11995-08-24
GGP11995-03-06
DDX11994-09-09
CZP11993-07-16
KQJ11993-03-09
LKL11992-08-20
JBQ11992-01-03
JZJ11991-12-20
DAB11991-12-09
DAK11991-10-28
DEW11988-02-10