The Binding Site, Ltd.
FDA 510(k) medical device clearances.
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.