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The Binding Site, Ltd.

115 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit (K231290)The Binding Site, Ltd.2024-01-24
HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) (K090920)The Binding Site, Ltd.2009-12-30
HUMAN BETA-2 MICROGLOBULIN KIT (K083289)The Binding Site, Ltd.2009-05-06
HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER (K082129)The Binding Site, Ltd.2009-02-10
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS (K081827)The Binding Site, Ltd.2008-12-19
BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG) (K081674)The Binding Site, Ltd.2008-10-15
HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER (K080384)The Binding Site, Ltd.2008-06-06
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER (K072889)The Binding Site, Ltd.2008-02-01
FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT (K070900)The Binding Site, Ltd.2007-11-30
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER (K062372)The Binding Site, Ltd.2007-06-21
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT (K062183)The Binding Site, Ltd.2006-11-21
IGD DIAGNOSTIC TEST KITS (K051299)The Binding Site, Ltd.2005-11-23
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER (K051915)The Binding Site, Ltd.2005-09-06
FREELITE HUMAN KAPPA AND LAMBDA KITS (K040009)The Binding Site, Ltd.2004-03-11
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER (K033811)The Binding Site, Ltd.2004-01-30
BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT (K032240)The Binding Site, Ltd.2003-09-29
BINDAZYME CLQ CIC EIA KIT (K031563)The Binding Site, Ltd.2003-09-10
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II (K031016)The Binding Site, Ltd.2003-07-15
BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT (K030238)The Binding Site, Ltd.2003-03-24
FREELITE HUMAN LAMBDA FREE KIT (K023131)The Binding Site, Ltd.2003-01-21
FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER (K023009)The Binding Site, Ltd.2003-01-21
MININEPH HUMAN B2-MICROGLOBULIN KIT (K014270)The Binding Site, Ltd.2002-08-15
HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER (K022083)The Binding Site, Ltd.2002-07-16
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER (K021081)The Binding Site, Ltd.2002-06-17
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB (K012292)The Binding Site, Ltd.2001-08-31
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T (K012296)The Binding Site, Ltd.2001-08-31
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T (K012295)The Binding Site, Ltd.2001-08-20
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA (K012291)The Binding Site, Ltd.2001-08-20
MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS (K011663)The Binding Site, Ltd.2001-07-30
MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL (K011662)The Binding Site, Ltd.2001-07-30
FREELITE LAMBDA FREE KIT (K010440)The Binding Site, Ltd.2001-04-26
FREELITE KAPPA FREE KIT (K010441)The Binding Site, Ltd.2001-04-26
ENA EIA KIT RANGE (K010146)The Binding Site, Ltd.2001-03-01
ENA EIA KIT (K010147)The Binding Site, Ltd.2001-03-01
ENA SCREEN EIA KIT (K010148)The Binding Site, Ltd.2001-02-23
ANA EIA DIAGNOSTIC TEST KIT (K004019)The Binding Site, Ltd.2001-02-15
KAPPA IMMAGE FREELITE KIT (K003669)The Binding Site, Ltd.2001-02-01
LAMBDA IMMAGE FREELITE KIT (K003671)The Binding Site, Ltd.2001-02-01
SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT (K002563)The Binding Site, Ltd.2000-10-26
SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT (K002564)The Binding Site, Ltd.2000-10-26
SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT (K002560)The Binding Site, Ltd.2000-10-26
SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT (K002561)The Binding Site, Ltd.2000-10-26
ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY (K001127)The Binding Site, Ltd.2000-08-30
C-REACTIVE PROTEIN ANTISERUM KIT (K001636)The Binding Site, Ltd.2000-08-24
HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY (K001556)The Binding Site, Ltd.2000-08-21
BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT (K991802)The Binding Site, Ltd.2000-05-05
BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT (K991801)The Binding Site, Ltd.2000-05-05
BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT. (K991803)The Binding Site, Ltd.2000-05-05
BINDAZYME ANTI-B2 SCREEN EIA TEST KIT. (K991804)The Binding Site, Ltd.2000-05-05
HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER (K000701)The Binding Site, Ltd.2000-04-27
BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA (K993612)The Binding Site, Ltd.1999-12-21
IGM MININEPH ANTISERUM (K981784)The Binding Site, Ltd.1999-12-21
BINDAZYME ANTI-DSDNA EIA KIT (K993727)The Binding Site, Ltd.1999-12-21
TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION (K981915)The Binding Site, Ltd.1999-12-20
C4 MININEPH ANTISERUM (K981785)The Binding Site, Ltd.1999-12-20
C3 MININEPH ANTISERUM (K981783)The Binding Site, Ltd.1999-12-20
IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS (K982100)The Binding Site, Ltd.1999-12-20
TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION (K981914)The Binding Site, Ltd.1999-11-26
IGA MININEPH ANTISERUM (K981786)The Binding Site, Ltd.1999-11-24
TOTAL HAEMOLYTIC COMPLEMENT RID KIT (K992488)The Binding Site, Ltd.1999-09-17
BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT (K984619)The Binding Site, Ltd.1999-02-23
ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT (K983694)The Binding Site, Ltd.1999-02-05
ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST (K983692)The Binding Site, Ltd.1999-02-05
ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT (K983695)The Binding Site, Ltd.1999-02-05
ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT (K983696)The Binding Site, Ltd.1999-02-05
ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT (K984165)The Binding Site, Ltd.1999-02-02
ANTI-TPO EIA DIAGNOSTIC TEST KIT (K984163)The Binding Site, Ltd.1999-02-02
HUMAN IGA SUBCLASS BNII COMBI KIT (K981912)The Binding Site, Ltd.1998-12-04
MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS (K981209)The Binding Site, Ltd.1998-10-22
BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT (K981929)The Binding Site, Ltd.1998-09-03
BINDAZYME ANTIGLIADIN IGG (K981644)The Binding Site, Ltd.1998-09-03
BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT (K981030)The Binding Site, Ltd.1998-07-20
BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT (K981029)The Binding Site, Ltd.1998-07-20
RETINOL BINDING PROTEIN RBP RID KIT (K973189)The Binding Site, Ltd.1997-09-29
ANCA COMBI DIAGNOSTIC TEST KIT (K965133)The Binding Site, Ltd.1997-05-21
HUMAN PROTEIN S RID TEST KIT (K951640)The Binding Site, Ltd.1997-04-21
RIT LIVER, KIDNEY, STOMACH IFA KIT (K955431)The Binding Site, Ltd.1996-04-23
RETINOL BINDING RID KIT (K955881)The Binding Site, Ltd.1996-03-22
HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT (K946069)The Binding Site, Ltd.1996-01-30
HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT (K946070)The Binding Site, Ltd.1996-01-30
HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KIT (K946068)The Binding Site, Ltd.1996-01-30
HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION) (K953207)The Binding Site, Ltd.1995-08-01
PLASMINOGEN RID TEST KIT (K941346)The Binding Site, Ltd.1994-09-09
IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER (K940422)The Binding Site, Ltd.1994-05-27
CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE) (K930987)The Binding Site, Ltd.1993-08-10
IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE (K931806)The Binding Site, Ltd.1993-07-16
HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE (K930247)The Binding Site, Ltd.1993-03-10
FIBRINOGEN RID TEST KIT (K922416)The Binding Site, Ltd.1993-03-09
IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC (K924769)The Binding Site, Ltd.1993-02-23
IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC (K924767)The Binding Site, Ltd.1993-02-23
EN TYPING CIE KIT FOR DIAGNOSTIC USE (K925118)The Binding Site, Ltd.1993-02-02
POWER SUPPLY (K924021)The Binding Site, Ltd.1993-01-28
ENA SCREENING CIE KIT FOR DIAGNOSTIC USE (K924262)The Binding Site, Ltd.1992-12-29
ELECTROPHORESIS TANK (K924020)The Binding Site, Ltd.1992-12-28
IGE EIA TEST KIT (K920087)The Binding Site, Ltd.1992-09-14
AL-ACID GLYCOPROTEIN RID KIT (K922417)The Binding Site, Ltd.1992-08-20
COMPLEMENT C1 INACTIVATOR KIT (K915431)The Binding Site, Ltd.1992-01-17
ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT (K913667)The Binding Site, Ltd.1992-01-03
ALPHA-2 MACROGLOBULIN TEST RID KIT (K914389)The Binding Site, Ltd.1991-12-20
CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT (K913668)The Binding Site, Ltd.1991-12-20
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