BEUDAMED
    FDA Registration Active 🇺🇸 United States

    R & D SYSTEMS, INC.

    Reg #: 2182501 · FEI: 2182501 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    58
    Establishment Types
    2
    Classifications
    10

    Registration Details

    Registration Name
    R & D SYSTEMS, INC.
    Registration Number
    2182501
    FEI Number
    2182501
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    614 Mckinley Pl Ne
    City
    MINNEAPOLIS
    State
    MN
    ZIP
    55413
    Country
    US

    Regulatory Submissions

    510(k) Number
    K936016

    Owner / Operator

    Firm Name
    R & D SYSTEMS, INC.
    Operator Number
    2182501
    Address
    614 MCKINLEY PL., N.E., --
    City
    Minneapolis
    State
    MN
    Postal Code
    55413
    Country
    US
    Correspondent
    Mary Anne Williams

    Products

    Device Name Product Code
    Assay, Erythropoietin GGT
    Mixture, Hematology Quality Control JPK
    Counter, Differential Cell GKZ
    Control, Hemoglobin GGM
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Control, Cell Counter, Normal And Abnormal JCN
    Calibrator For Red-Cell And White-Cell Counting KSA
    Calibrator For Platelet Counting KRY
    Calibrator For Cell Indices KRX
    Calibrator For Hemoglobin And Hematocrit Measurement KRZ

    Proprietary Names

    Quantikine IVD Erythropoitin ELISA Retic-I Retic Hematology Control StatusFlow Lo Glu/Hgb Whole Blood Control CBC-XE Hematology Control Bio Rad Liquicheck Hematology Control (X) CBC-X Hematology Control XERet Hematology Control Body Fluid-I Control 4K Retic Hematology Control CELL-DYN Drift Control CBC-3K CBC-LINE for HemoCue Linearity Kit PLT-LINE Linearity Kit CBC-LINE Linearity Kit CBC-LINE Ultra Low Linearity Kit CBC-LINE Low Range Linearity Kit CBC-LINE Ultra Low Plus RBC Hematology Linearity Kit CBC-5D Hematology Control CBC-PIX Hematology Control R&D ADVIA Retic plus Sickle QC Hematology Control CD-CAL CBC-SYS Hematology Control Status FlowPro Body Fluid Control 3K Retic Hematology Control Leuko-Reduced Plt Control R&D CBC-DH Hematology Control R&D CBC-XR Hematology Control R&D CBC-ST Hematology Control R&D CBC-XN Hematology Control CBC-CAL Plus for Abacus CBC-CAL Plus CBC-CAL Plus for Mindray NEK-CAL Tech -Cal BC-5D Hematology Controls R&D Retic-I for DxH-800 Status Flow CBC-3D+CRP Hematology Control Quantikine Erythropoitin Control R&D Platelet-Trol Extended CBC-Tech CBC-3D for Mindray CBC-3D SEDRite Plus SEDRite III Leuko-Reduced RBC Control HCT Extended Control RET-LINE Linearity Kit RET-LINE B Linearity Kit CBC-7 for Hemocue CBC-8 CBC-7 HGB Extended HC WBC Hematology Control

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)