FDA.reportPublic FDA data

THE BINDING SITE, INC.

Matched from indexed company URL: THE BINDING SITE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20835662083566THE BINDING SITE, INC.1Y2026-01-019606 Kearny Villa Rd SAN DIEGO CA US 92126
30124710763012471076THE BINDING SITE1N2026-01-01Unit 27-29, 31-33 Sovereign Road Kings Norton Business Centre Kings Norton Birmingham GB B30 3HN

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05051700020602EXENT® Immunoglobulin Isotypes (GAM) Control Pack - MSQ801.M+441214569500info@bindingsite.com
05051700020640EXENT® Diluent 1 - IK876+441214569500info@bindingsite.com
05051700020657EXENT® Elution buffer 1 - IK877+441214569500info@bindingsite.com
05051700020664EXENT® HCCA MALDI Matrix Pack - IK820+441214569500info@bindingsite.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2087441251045326K992488TOTAL HAEMOLYTIC COMPLEMENT RID KITDAE1999-09-17
2087441888668068K982100IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITSCFN1999-12-20
2087441516182836K981912HUMAN IGA SUBCLASS BNII COMBI KITCFN1998-12-04
2087441285451648K981786IGA MININEPH ANTISERUMCFQ1999-11-24
2087441377739364K981785C4 MININEPH ANTISERUMDBI1999-12-20
2087441634459319K981784IGM MININEPH ANTISERUMCFN1999-12-21
2087442009387773K981783C3 MININEPH ANTISERUMCZW1999-12-20
2087441482679632K974111QUIDEL CH50 EQ EIADAE1998-07-29
2087441696358230K950383APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KITJHN1995-09-15
2087441883225307K950382APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KITJHN1995-09-15
2087441958171307K950015HUMAN PROTEIN C RID TEST KITGGP1995-03-06
2087441333238867K946069HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KITJZG1996-01-30
2087441424292612K946068HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KITJZG1996-01-30
2087441167776567K942326HUMAN C5 RID KITSDAY1995-08-24
2087441967917429K941346PLASMINOGEN RID TEST KITDDX1994-09-09
2087441611114035K940422IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZERDFZ1994-05-27
2087442032767548K931806IGA SUBCLASS RID KIT FOR DIAGNOSTIC USECZP1993-07-16
2087441817937550K924769IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFICCFF1993-02-23
2087441987626170K924767IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFICCFF1993-02-23
2087441742670379K924262ENA SCREENING CIE KIT FOR DIAGNOSTIC USELLL1992-12-29
2087441693942310K922417AL-ACID GLYCOPROTEIN RID KITLKL1992-08-20
2087441349954811K922416FIBRINOGEN RID TEST KITKQJ1993-03-09
2087441070406130K915431COMPLEMENT C1 INACTIVATOR KITDBA1992-01-17
2087441222808374K914391ALBUMIN TEST RID KITDCF1991-12-10
2087441054858792K914390TRANSFERRIN RID KITDDG1991-12-09
2087441837065482K914388C1 RID KITDAK1991-10-28
2087441616062223K913672PREALBUMIN IMMUNOLOGICAL NL TEST KITJZJ1991-12-20
2087441330733796K913671HUMAN IGD IMMUNOLOGICAL NL TEST KITCZJ1991-12-02
2087441147381272K913670HAPTOGLOBIN IMMUNOLOGICAL TEST KITDAB1991-12-09
2087441093355546K913668CAERULOPLASMIN IMMUNOLOGICAL NL TEST KITDDB1991-12-20
2087441491760253K913667ANTITHROMBIN III IMMUNOLOGICAL NL TEST KITJBQ1992-01-03
2087441717050566K913666ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KITDEM1991-12-09
2087441649897733K905633HUMAN C-REACTIVE PROTEIN RID KITDCK1991-07-22
2087441883778239K902382C3C AND C4 RID KITSCZW1990-09-07
2087441318573676K881828IMMUNOGLOBULIN M TEST SYSTEMCFQ1988-06-06
2087441382020146K881827IMMUNOGLOBULIN A TEST SYSTEMCFQ1988-06-10
2087441135375405K875356IMMUNOGLOBULIN G & G SUBCLASSESDEW1988-02-10
2087441185499225K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitDFH2025-05-23
352931259046408K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitDFH2025-05-23
2087441304712122K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserSGG2025-10-17
2087441983177545K231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitDFH2024-01-24
2087441546988829K192116Human IgA liquid reagent kit for Use on SPAPlusCFN2019-09-04
2087441092403938K191985Optilite IgA KitCFN2019-08-19
2087442013065718K191635Optilite IgM KitCFN2019-07-15
2087441261684794K191465Human IgM Kit for use on SPAPlusCFN2019-06-27
2087441863304790K190686Optilite IgM CSF KitCFN2019-05-28
2087441644999523K183151Optilite IgA CSF KitCFN2019-01-23
2087441730015935K180099Optilite High Sensitivity C-Reactive Protein KitDCN2018-10-12
2087441252840085K173732Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free KitDFH2018-08-23
352932012048211K173732Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free KitDFH2018-08-23
2087441384604531K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsDCN2018-02-28
2087441846934416K172613Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda KitPCN2018-02-15
2087441648020833K162263Optilite Rheumatoid Factor KitDHR2017-05-03
2087441281734701K161982C-Reactive Protein Kit for use on SPAPLUSDCN2017-04-05
2087441128858699K161854Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUSPCN2016-10-04
2087441651727273K160819Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda KitOPX2016-06-16
2087441940160570K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSDHR2016-12-07
2087441471822364K153560Optilite Low Level Albumin KitDCF2016-08-25
2087441458002373K152389Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda KitPDE2015-12-18
2087441578793815K151759Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUSOPX2015-11-06
2087441846245479K150658Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free KitDFH2015-08-26
352931925379135K150658Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free KitDFH2015-08-26
2087441745977822K150526Optilite IgG4 KitCFN2015-05-30
2087441857418276K150412Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 CalibratorDAE2015-08-28
2087441189655148K143118Human Microalbumin kit for use on SPAPLUSDCF2015-05-26
2087441889970509K142735The Optilite IgG3 kitCFN2014-12-21
2087441558316619K141100OPTILITE C1 INACTIVATOR KITDBA2014-07-18
2087441475165992K140686HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUSPDE2014-08-06
2087441871511159K140664HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUSDEB2014-04-16
2087441913398499K140396FREELITE HUMAN LAMBDA FREE KITDEH2014-04-16
2087441344604653K140105HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNIIOPX2014-03-18
2087441549863724K132555HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KITPCN2013-12-20
2087441324630976K123256HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUSDEM2013-07-03
2087441480382952K122965HUMAN CAERULOPLASMIN KITDDB2013-06-03
2087441550493380K122304HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUSDBA2013-04-15
2087441158704681K122066HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUSJZG2012-08-30
2087441074103822K121045HUMAN ALBUMIN CSF KITDCF2013-06-19
2087441231017519K120901HUMAN IGA CSF KIT FOR USE ON SPAPLUSCFN2013-05-30
2087441422522145K120750HUMAN IGM CSF KITCFN2013-05-17
2087441253554178K120749HUMAN IGG CSF KITCFN2013-05-17
2087441661433691K120236TRANSFERRIN KIT FOR USE ON THE SPAPLUSDDG2013-02-13
2087441999595025K120056HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSERDFH2013-04-01
2087441144306365K113823HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KITCFN2013-03-27
2087441637238808K113349HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FODAE2012-07-11
2087441380685681K103824HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUSCFN2012-02-27
2087442053104845K100588HUMAN IGA2 KIT FOR USE ON THE SPAPLUSCFN2010-08-16
2087442027054608K100455SPAPLUS ANALYZERDBI2010-09-03
2087441391499207K100179SPAPLUSCZW2010-08-13
2087441501160966K092450HUMAN IGD KIT FOR USE ON SPAPLUSCZJ2009-12-28
2087441209902366K090920HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)CFN2009-12-30
2087441398929402K083289HUMAN BETA-2 MICROGLOBULIN KITJZG2009-05-06
2087441339122772K082823HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITSCFN2010-03-01
2087441876111202K082129HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZERCFN2009-02-10
2087441225543825K081827HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUSCFN2008-12-19
2087441855791160K080384HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSERNDY2008-06-06
2087441184677321K072889HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSERCFN2008-02-01
2087441203119694K072166CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZERNDY2008-01-24
352931004520135K070900FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KITDFH2007-11-30
2087441085837749K070900FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KITDFH2007-11-30
2087441604605587K062372FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZERDFH2007-06-21
2087441900905513K051915FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZERDFH2005-09-06
2087441331176229K051299IGD DIAGNOSTIC TEST KITSCZJ2005-11-23
2087441816527450K042152BINDING SITE IGG SUBLCASS OLYMPUS KITSCFN2004-11-22
2087441773233944K041891MININEPH HUMAN RHEUMATOID FACTOR KITDHR2004-11-05
2087441448731755K040009FREELITE HUMAN KAPPA AND LAMBDA KITSDFH2004-03-11
2087441458439225K033811FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZERDEH2004-01-30
2087441606951727K031016FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER IIDEH2003-07-15
2087441039742201K023131FREELITE HUMAN LAMBDA FREE KITDEH2003-01-21
2087441968137011K023009FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZERDFH2003-01-21
2087441472522715K022083HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSERCFN2002-07-16
2087441521335168K021081HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSERDFZ2002-06-17
2087441662235870K014270MININEPH HUMAN B2-MICROGLOBULIN KITJZG2002-08-15
2087441887196957K012295HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.TCFN2001-08-20
2087441315565991K012292HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TBCFN2001-08-31
2087441570245941K011662MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROLDDG2001-07-30
2087441799291686K011568RANDOX LIPOPROTEINJIS2001-09-28
2087441051549601K010441FREELITE KAPPA FREE KITDEH2001-04-26
2087441703244075K010440FREELITE LAMBDA FREE KITDEH2001-04-26
2087441952907946K010147ENA EIA KITLLL2001-03-01
2087441066357580K003671LAMBDA IMMAGE FREELITE KITDEH2001-02-01

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CFN272019-09-04
DFH162025-05-23
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

PMN#

160 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next