The Binding Site, Ltd.
The Binding Site, Ltd. holds FDA 510(k) medical device clearances, first cleared 1988, most recent 2024.
Top product codes for The Binding Site, Ltd.
Recent clearances by The Binding Site, Ltd.
1–100 of 115- K231290 — Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
- K090920 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
- K083289 — HUMAN BETA-2 MICROGLOBULIN KIT
- K082129 — HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
- K081827 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
- K081674 — BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)
- K080384 — HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
- K072889 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
- K070900 — FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT
- K062372 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
- K062183 — FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
- K051299 — IGD DIAGNOSTIC TEST KITS
- K051915 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER
- K040009 — FREELITE HUMAN KAPPA AND LAMBDA KITS
- K033811 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER
- K032240 — BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
- K031563 — BINDAZYME CLQ CIC EIA KIT
- K031016 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II
- K030238 — BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
- K023009 — FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER
- K023131 — FREELITE HUMAN LAMBDA FREE KIT
- K014270 — MININEPH HUMAN B2-MICROGLOBULIN KIT
- K022083 — HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER
- K021081 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER
- K012292 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB
- K012296 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T
- K012291 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA
- K012295 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T
- K011662 — MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
- K011663 — MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS
- K010440 — FREELITE LAMBDA FREE KIT
- K010441 — FREELITE KAPPA FREE KIT
- K010146 — ENA EIA KIT RANGE
- K010147 — ENA EIA KIT
- K010148 — ENA SCREEN EIA KIT
- K004019 — ANA EIA DIAGNOSTIC TEST KIT
- K003669 — KAPPA IMMAGE FREELITE KIT
- K003671 — LAMBDA IMMAGE FREELITE KIT
- K002560 — SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
- K002561 — SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT
- K002563 — SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
- K002564 — SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
- K001127 — ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY
- K001636 — C-REACTIVE PROTEIN ANTISERUM KIT
- K001556 — HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY
- K991801 — BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT
- K991802 — BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT
- K991803 — BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.
- K991804 — BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.
- K000701 — HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER
- K981784 — IGM MININEPH ANTISERUM
- K993612 — BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA
- K993727 — BINDAZYME ANTI-DSDNA EIA KIT
- K981783 — C3 MININEPH ANTISERUM
- K981785 — C4 MININEPH ANTISERUM
- K981915 — TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION
- K982100 — IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
- K981914 — TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION
- K981786 — IGA MININEPH ANTISERUM
- K992488 — TOTAL HAEMOLYTIC COMPLEMENT RID KIT
- K984619 — BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT
- K983692 — ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST
- K983694 — ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT
- K983695 — ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT
- K983696 — ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT
- K984163 — ANTI-TPO EIA DIAGNOSTIC TEST KIT
- K984165 — ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT
- K981912 — HUMAN IGA SUBCLASS BNII COMBI KIT
- K981209 — MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS
- K981644 — BINDAZYME ANTIGLIADIN IGG
- K981929 — BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT
- K981029 — BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT
- K981030 — BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT
- K973189 — RETINOL BINDING PROTEIN RBP RID KIT
- K965133 — ANCA COMBI DIAGNOSTIC TEST KIT
- K951640 — HUMAN PROTEIN S RID TEST KIT
- K955431 — RIT LIVER, KIDNEY, STOMACH IFA KIT
- K955881 — RETINOL BINDING RID KIT
- K946068 — HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KIT
- K946069 — HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT
- K946070 — HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT
- K953207 — HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION)
- K941346 — PLASMINOGEN RID TEST KIT
- K940422 — IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER
- K930987 — CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE)
- K931806 — IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE
- K930247 — HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE
- K922416 — FIBRINOGEN RID TEST KIT
- K924767 — IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC
- K924769 — IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC
- K925118 — EN TYPING CIE KIT FOR DIAGNOSTIC USE
- K924021 — POWER SUPPLY
- K924262 — ENA SCREENING CIE KIT FOR DIAGNOSTIC USE
- K924020 — ELECTROPHORESIS TANK
- K920087 — IGE EIA TEST KIT
- K922417 — AL-ACID GLYCOPROTEIN RID KIT
- K915431 — COMPLEMENT C1 INACTIVATOR KIT
- K913667 — ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT
- K913668 — CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT
- K913672 — PREALBUMIN IMMUNOLOGICAL NL TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.