BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIONOSTICS, INC.

    Reg #: 1220649 · FEI: 1220649 · Expires 2026
    View on FDA
    Products
    27
    Proprietary Names
    105
    Establishment Types
    2
    Classifications
    27

    Registration Details

    Registration Name
    BIONOSTICS, INC.
    Registration Number
    1220649
    FEI Number
    1220649
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7 JACKSON RD.
    City
    Devens
    State
    MA
    ZIP
    01434
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141829

    Owner / Operator

    Firm Name
    BIONOSTICS, INC.
    Operator Number
    1220649
    Address
    7 JACKSON RD., --
    City
    Devens
    State
    MA
    Postal Code
    01434
    Country
    US
    Correspondent
    Yifei Wang

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Glucose Oxidase, Glucose CGA
    Glucose Dehydrogenase, Glucose LFR
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Plasma, Coagulation Control GGN
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Assay, Carboxyhemoglobin GHS
    Electrode, Ion Specific, Calcium JFP
    Instrument, Hematocrit, Automated GKF
    System, Hemoglobin, Automated GKR
    Control, Hematocrit GLK
    Electrode, Ion Specific, Potassium CEM
    Acid, Lactic, Enzymatic Method KHP
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion-Specific, Chloride CGZ
    Osmolality Of Tears OND
    Controls For Blood-Gases, (Assayed And Unassayed) JJS
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Instrument, Coagulation KQG
    Mixture, Hematology Quality Control JPK
    Standards And Controls, Hemoglobin, Normal And Abnormal GFS
    Control, Fecal Occult Blood OSL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Drug Mixture Control Materials DIF
    Calculator/Data Processing Module, For Clinical Use JQP
    Tube, Collection, Capillary Blood GIO

    Proprietary Names

    ARKRAY Assure Dose Glucose Control Solution TRUEmetrix Glucose Control JJX GlucoVitaal HbA1c Control Assure Control Control Solution ARKRAY GLUCOCARD glucose control solution PHLORINGDH APOC i-STAT CHEM 8+ Control APOC i-STAT 1 Calibration Verification Kit APOC i-STAT TriControls Calibration Verification Kit APOC i-STAT CHEM 8+ Calibration Verifier Kit APOC i-STAT 1 Controls JJX Advocate Glucose Control directCheck Whole Blood ACT+ Control directCheck Whole Blood ACT-Low Range Control JJX Siemens RapidLab High Glucose Control OPTI Medical OPTI-Check PLUS Control One Touch Select Plus Control Solution Assure Control – Control Solution GLK Instrumentation Lab GEM Crit PVP Kit GLK Instrumentation Lab GEM Crit Check JJY Instrumentation Lab GEM Creatine Control JJX TearLab Osmolarity Control UniStrip Glucose Control Siemens RapidQC CVM Siemens RapidQC COMPLETE Control GMate Voice Glucose Control HepCheck Whole Blood Control directCheck High Dose Thrombin Time (HiTT) Control directCheck PRO Protime Control Contour Next Control Solution JJX Roche AccuCheck Performa Glucose Control Solution RNA Medical QCHGB Control Glucose Control for Broadmaster Biotech BGMS JJX Bionime Rightest Glucose Control Solution JJX Bionime G700 Glucose Control Solution directCheck Whole Blood Citrated PT/APTT Control GEM Check APTT Control directCheck Whole Blood Citrated PT Control GEM Check ACT Control directCheck Whole Blood PT Control GEM Check Citrated PT Control GEM Check PT Control GEM Check ACT Low Range Control directCheck Whole Blood APTT Control Waters OXYCOM tHb/SO2 Control RNA Medical CC527 Control JJX Clever Choice Glucose Control JJX LifeScan OneTouch Verio Glucose Control Solution Roche AUTOTROL PLUS B Control Roche COMBITROL PLUS B Control Assure Dose Control Contour TS Controls MEDICA EasyQC Hematocrit Control JJY Instrumentation Lab GEM Crit Check Control JJY Instrumentation Lab GEM CVP Kit JJY Instrumentation Lab Gem Crit PVP Kit JJY Instrumentation Lab GEM PVP Kit JJX Easy Check Glucose Control Assure Dose Glucose Control EMPECS Glucose Control Enterix iFOB Control Roche AUTOTROL TS PLUS Control Roche COMBITROL TS PLUS Control BIO-RAD LiquiCheck Blood Gas Control JJX FORA Glucose Control ESA LeadCare II Lead Control RNA Medical QC823 Range Control RNA Medical CVC123 CVC Kit RNA Medical QC823 Control JJX Arkray Assure Dose Glucose Control ACCU-CHEK Inform II Linearity Test Kit ACCU-CHEK Inform II Controls LifeScan GlucoTouch Control Solution LifeScan OneTouch Select Glucose Control Solution LifeScan OneTouch Horizon Glucose Control Solution LifeScan OneTouch Vita Glucose Control Solution LifeScan OneTouch Ultra Glucose Control Solution LifeScan Verio Glucose Control Solution JJX ANDON Health Glucose Control JJX BeneCheck Glucose Control Solution Siemens RapidQC Hematocrit Control Siemens RapidQC Hematocrit CVM Kit JJX Major Glucose Control Solution various ITC Direct Check Coagulation Controls, Normal and Abnormal Clever Choice Glucose Control Glucose Control Solution for EPS Biotech BGMS RNA Medical Glucose & B-Ketone CVC Abbott Diabetes Care Freestyle Glucose Control FreeStyle Glucose Control MEDICA EasyQC BG/ISE Control JJX Roche Accu-Chek Compact Glucose Control OPTI Medical OPTI-Check Control RNA Medical QC253 CO-Oximeter Control RNA Medical CVC223 CO-Oximeter CVC Prodigy Glucose Control RNA Medical CC527 Blood Gas, Electrolyte, CO-Oximeter Control Hemochron Whole Blood ACT Control BIO-RAD LiquiCheck Blood Gas, Electrolyte, Glucose Control Cambridge Sensors microDot Glucose Control JJX Advocate Glucose Control Solution iBGStar Glucose Control RNA Medical EC 220 End Caps RNA Medical CT095 Safe-Wrap Tubes RNA Medical CT220 Safe-Wrap Tubes JJX Roche AccuCheck AVIVA Glucose Control

    Establishment Types

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