BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sysmex America, Inc.

    Reg #: 3009711478 · FEI: 3009711478 · Expires 2026
    View on FDA
    Products
    30
    Proprietary Names
    395
    Establishment Types
    3
    Classifications
    30

    Registration Details

    Registration Name
    Sysmex America, Inc.
    Registration Number
    3009711478
    FEI Number
    3009711478
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    577 Aptakisic Rd
    City
    Lincolnshire
    State
    IL
    ZIP
    60069
    Country
    US

    Regulatory Submissions

    510(k) Number
    K981761

    Owner / Operator

    Firm Name
    SYSMEX CORPORATION
    Operator Number
    9014170
    Address
    4-4-4 TAKATSUKADAI, NISHI-KU
    City
    KOBE
    State
    JP-NOTA
    Postal Code
    651-2271
    Country
    JP

    Products

    Device Name Product Code
    Counter, Differential Cell GKZ
    Counter, Cell, Automated (Particle Counter) GKL
    Mixture, Hematology Quality Control JPK
    Mixture, Control, White-Cell And Red-Cell Indices GLQ
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    General Purpose Reagent PPM
    Instrument, Coagulation, Automated GKP
    Device, Automated Cell-Locating JOY
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Diluent, Blood Cell GIF
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Calibrator, Secondary JIT
    Medical Device Data System OUG
    Container, Specimen, Non-Sterile NNI
    Slide Stainer, Automated KPA
    Mixer, Blood Tube GLE
    Counter, Urine Particle LKM
    Calibrator For Cell Indices KRX
    Calibrator, Surrogate JIW
    Control, Platelet GJP
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Stain, Reticulocyte GJH
    Calculator/Data Processing Module, For Clinical Use JQP
    Calibrator For Red-Cell And White-Cell Counting KSA
    Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis PER
    Products, Red-Cell Lysing Products GGK
    Urinalysis Controls (Assayed And Unassayed) JJW
    Reagents, Specific, Analyte MVU

    Proprietary Names

    XP-300 Sysmex XR-Series (XR-20) Automated Hematology Analyzer XN-20 XN-10 pocH-100i e-CHECK(XS) e-CHECK XW-100 Barcode Terminal (BT-40) ST-41 ST-42 CV-60 ST-40 CV-50 CV-55 CA CLEAN I CELLCLEAN CELLCLEAN AUTO Concentrated phosphate buffer for SP pH 6.6 Concentrated phosphate buffer for SP pH 7.2 Concentrated phosphate buffer for SP pH 6.8 Concentrated phosphate buffer for SP pH 7 XW CELLCLEAN CyFlow CLEAN CA CLEAN II CN-COAGWASHER CA-620 CA-660 UD-10 XN-L CHECK Option Sampler SA-90 XS-1000i sampler (OPSU-11) HST-N SA-31 SA-30 AlphaN-SPSU CV-65 RB-10 Pneumatic Unit (PU-17) SA-02 RU-10 SA-10 SA-20 SA-21 SA-01 CF-70 RR-20 RR-10 COMPLETE OPSU-6 AlphaN-XESU RU-21 TS-10 RU-20 CV-70 TU-40 CF-60 SA-51 U-RDU CV-11 TH-11 BT-50 TS-01 Automated Tube Sorter TA-01 Automated Tube Archiver Urine Sample Transportation Unit ST-10 Urine Sample Transportation Unit ST-11 Urine Sample Transportation Unit ST-12 EIGHTCHECK-3WP IQAS EIGHTCHECK-3WP CELLPACK DFL Cellpack Cellsheath CELLSHEATH CCS UF-CELLSHEATH XW pack D UF-CELLPACK CR UF-CELLPACK SF Cellsheath C CELLPACK DCL UF II PACK SED UF II Sheath pocH-pack D CELLPACK S RETSEARCH II UF II PACK-BAC CELLPACK DST XW QC CHECK XN-350 XN-550 XN-430 XN-530 XN-450 XN-330 HISCL Immuno Multi Control HISCL TSH Calibrator Automated Immunoassay System HISCL-800 HISCL TSH Assay Kit Urinalysis Data Manager (UDM) Sysmex WAM (Work Area Management) SB Cuvette Reaction Tube Cuvette XT-4000i XE-2100D XN CHECK XS-Series (XS-800i, XS-1000i) SP-50 SP-1000i SP-10 UF-1000i XN CAL PF XE-2100DC UF-CALIBRATOR UF-1000i UF WAM Platelet CHECK X-CAL Calibrator UF-5000 AUTOMATED HEMATOLOGY ANALYZER XW-100 CA CAL S XN CHECK BF XQ-Series (XQ-520) Automated Hematology Analyzer XQ-Series (XQ-320) Automated Hematology Analyzer Sysmex XN-L Automated Hematology Analyzer Sysmex XR-Series (XR-10) Automated Hematology Analyzer UFII SEARCH-SED UFII SEARCH-BAC UF-Fluorocell CR UF-Fluorocell SF Caresphere Workflow Solution SCS-1000 Calibrator Automated Blood Coagulation Analyzer CN-6000 Automated Blood Coagulation Analyzer CN-3000 Lysercell WPC Lysercell WNR Lysercell WDF Sulfolyser Stromatolyser-4DS XW pack L Stromatolyser-IM Stromatolyser-4DL Stromatolyser-3WP Stromatolyser-WH Stromatolyser-NR Stromatolyser-FB pocH-pack L Stromatolyser-NR(L) Lysercell WDF II XN-11 XN CAL XS-1000iC HISCL-5000 UF-CONTROL UF II CALIBRATOR WRP CHECK WRP CHECK EX CS-5100 Sysmex XN-10 Automated Hematology Analyzer CS-2500 e-CHECK(XE) CyFlow CD25 FITC CyFlow CD16 Pacific Orange CyFlow CD79a PE CyFlow CD10 APC CyFlow CD3 Alexa Fluor 700 CyFlow CD8 Pacific Blue CyFlow CD41 FITC CyFlow CD22 APC CyFlow CD3 Pacific Blue CyFlow CD5 APC CyFlow CD3 FITC CyFlow CD38 Pacific Blue CyFlow CD27 PE CyFlow CD45 Pacific Blue CyFlow CD13 FITC CyFlow CD41 PE CyFlow CD8 Pacific Orange CyFlow Lambda-LC FITC CyFlow Kappa-LC Pacific Blue CyFlow CD4 FITC CyFlow CD25 APC CyFlow CD56 FITC CyFlow CD117 PE CyFlow CD45 FITC CyFlow CD8 PE CyFlow CD20 Pacific Blue CyFlow CD4 PE CyFlow CD8 FITC CyFlow CD20 PerCP-Cy5.5 CyFlow CD33 FITC CyFlow CD25 PE CyFlow CD27 FITC CyFlow CD19 APC CyFlow CD8 PerCP-Cy5.5 CyFlow CD41 APC CyFlow CD38 FITC CyFlow CD4 APC CyFlow CD33 APC CyFlow CD10 FITC CyFlow CD16 PerCP CyFlow CD16 FITC CyFlow CD33 PerCP-Cy5.5 CyFlow CD33 PE-Cy7 CyFlow CD38 PE CyFlow CD4 PerCP-Cy5.5 CyFlow CD20 APC CyFlow Kappa-LC FITC CyFlow CD3 APC CyFlow CD19 Alexa Fluor 700 CyFlow CD45 APC-Cy7 CyFlow CD61 FITC CyFlow CD4 Pacific Blue CyFlow CD10 Alexa Fluor 700 CyFlow CD16 PE CyFlow CD235a PE CyFlow CD13 PE CyFlow CD8 PerCP CyFlow Lambda-LC APC CyFlow CD5 Pacific Blue CyFlow CD56 PE CyFlow CD117 PE-Cy7 CyFlow CD103 FITC CyFlow CD117 FITC CyFlow CD22 PE CyFlow CD71 APC-Cy7 CyFlow Kappa-LC APC CyFlow CD5 FITC CyFlow CD13 PE-Cy7 CyFlow CD2 PE-Cy7 CyFlow CD16 APC CyFlow CD56 PerCP-Cy5.5 CyFlow CD8 APC CyFlow CD13 APC CyFlow CD5 PE-Cy7 CyFlow CD56 APC CyFlow CD8 Alexa Fluor 700 CyFlow CD45 PerCP-Cy5.5 CyFlow Kappa-LC PE CyFlow CD235a FITC CyFlow CD10 PE CyFlow CD123 FITC CyFlow CD19 PerCP-Cy5.5 CyFlow Lambda-LC PE CyFlow CD33 PE CyFlow CD2 FITC CyFlow HLA-DR Pacific Blue CyFlow CD23 PE CyFlow HLA-DR FITC CyFlow MPO FITC CyFlow CD45 Pacific Orange CyFlow CD11b PE-Cy7 CyFlow CD45 APC CyFlow CD20 PE CyFlow CD3 APC-Cy7 CyFlow CD117 APC-Cy7 CyFlow CD103 PE CyFlow CD7 PE CyFlow CD38 PerCP-Cy5.5 CyFlow CD16 PE-Cy7 CyFlow CD20 APC-Cy7 CyFlow HLA-DR Alexa Fluor 700 CyFlow CD4 APC-Cy7 CyFlow CD8 PE-Cy7 CyFlow CD10 PE-DyLight 594 CyFlow CD19 PE-Cy7 CyFlow CD34 PerCP-Cy5.5 CyFlow CD4 PE-Cy7 CyFlow CD45 PE-Cy7 CyFlow CD20 PE-Cy7 CyFlow CD117 Alexa Fluor 700 CyFlow TCR gamma/delta PE CyFlow CD138 APC CyFlow CD13 PerCP-Cy5.5 CyFlow CD20 FITC CyFlow CD24 APC CyFlow CD14 PE CyFlow CD14 FITC CyFlow CD2 APC CyFlow MPO APC CyFlow CD8 PE-DyLight 594 CyFlow CD2 Pacific Blue CyFlow TCR gamma/delta PE-Cy7 CyFlow CD3 PE-Cy7 CyFlow CD1a PE CyFlow CD10 APC-Cy7 CyFlow CD5 PerCP-Cy5.5 CyFlow CD16 Alexa Fluor 700 CyFlow CD1a APC CyFlow CD20 PE-DyLight 594 CyFlow CD38 APC-Cy7 CyFlow CD11c PE-Cy7 CyFlow CD7 APC CyFlow CD11b Alexa Fluor 700 CyFlow CD27 Pacific Blue CyFlow HLA-DR PE CyFlow CD19 PE-DyLight 594 CyFlow CD19 APC-Cy7 CyFlow CD43 APC-Cy7 CyFlow CD7 PE-DyLight 594 CyFlow CD71 Alexa Fluor 700 CyFlow CD19 PE CyFlow MPO PE CyFlow CD34 PE-DyLight 594 CyFlow CD123 PerCP-Cy5.5 CyFlow CD19 FITC CyFlow CD7 FITC CyFlow CD79a PerCP-Cy5.5 CyFlow CD56 PE-DyLight 594 CyFlow CD14 Alexa Fluor 700 CyFlow CD138 FITC CyFlow CD103 APC CyFlow CD14 Pacific Blue CyFlow CD7 Pacific Blue CyFlow CD2 PE CyFlow CD11b FITC CyFlow CD8 APC-Cy7 CyFlow CD31 PE CyFlow CD34 FITC CyFlow CD79a APC CyFlow CD138 PerCP-Cy5.5 CyFlow CD79a FITC CyFlow CD200 PE CyFlow CD14 APC-Cy7 CyFlow CD71 PE CyFlow CD34 APC CyFlow CD11c APC CyFlow CD15 FITC CyFlow CD14 PerCP-Cy5.5 CyFlow CD34 PE-Cy7 CyFlow CD13 PE-DyLight 594 CyFlow CD14 APC CyFlow CD14 PE-DyLight 594 CyFlow CD11c PE CyFlow CD64 Alexa Fluor 700 CyFlow CD23 PE-DyLight 594 CyFlow CD64 APC-Cy7 CyFlow CD117 PerCP-Cy5.5 CyFlow CD7 PerCP-Cy5.5 CyFlow TCR gamma/delta FITC CyFlow CD200 APC CyFlow CD21 Pacific Blue CyFlow CD25 Pacific Blue CyFlow CD9 Pacific Blue CyFlow CD34 PE CyFlow CD30 APC CyFlow CD157 PE CyFlow CD3 PE-DyLight 594 CyFlow CD123 PE CyFlow CD23 APC CyFlow CD123 PE-DyLight 594 CyFlow CD16 Pacific Blue CyFlow CD8 PE-Cy5 CyFlow CD16 PE-DyLight 594 CyFlow CD138 Pacific Blue CyFlow Lambda-LC Alexa Fluor 488 CyFlow CD3 PerCP-Cy5.5 CyFlow CD79b PE CyFlow Kappa-LC Alexa Fluor 488 CyFlow CD11c APC-Cy7 CyFlow CD24 Alexa Fluor 700 CyFlow CD64 FITC CyFlow CD3 PE-Cy5 CyFlow MPO PE-Cy7 CyFlow CD64 PE-Cy7 CyFlow Ki-67 PE CyFlow CD24 PE_DyLight 594 CyFlow Perforin PE CyFlow CD45R0 FITC CyFlow CD36 FITC CyFlow IgD PE CyFlow CD305 FITC CyFlow CD28 APC CyFlow CD5 Alexa Fluor 700 CyFlow IgM PerCP-Cy5.5 CyFlow CD15 Pacific Blue CyFlow CD7 PE-Cy7 CyFlow CD22 PerCP-Cy5.5 CyFlow CD57 FITC CyFlow CD26 PE CyFlow CD14 PE-Cy7 CyFlow CD25 PE-Cy5 CyFlow HLA-DR APC-Cy7 CyFlow TdT FITC CyFlow IgG (Fab) PE-Cy7 CyFlow CD11c FITC CyFlow CD56 PE-Cy7 CyFlow CD36 APC CyFlow CD23 PerCP-Cy5.5 CyFlow CD3 Pacific Orange CyFlow CD11b APC-Cy7 CyFlow CD62P Biotin CyFlow CD81 Alexa Fluor 700 CyFlow CD38 PE-Cy7 CyFlow IFN-gamma FITC CyFlow CD200 PE-Cy7 CyFlow CD34 Pacific Blue CyFlow CD10 PE-Cy7

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility