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    BIO-ANALYSIS, INC.

    FDA registration
    BIO-ANALYSIS, INC.·3 products·🇺🇸 United States

    D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection and analysis.

    FDA Enforcement
    Class II ·Terminated·Bio-Rad Laboratories, Inc.·April 2, 2014

    Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette; Model Numbers: 220-0101 (Reorder Pack); 220-0115 (Program Diskette); Distributed and manufactured by: Bio-Rad Laboratories, Inc., Hercules, CA System Overview: The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, A1 c) in whole blood. The separation is based on the principles of high performance liquid chromatography. Technology Overview: The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-1 0 incorporates the use of a dedicated software system for instrument control, data collection and analysis. The D-10 Software performs reduction of raw data collected from each analysis. Reagent Kit Information: The D-10 Hemoglobin A1c Program utilizes principles of ion-exchange High-performance liquid chromatography (HPLC). The D-10 Hemoglobin Ale Program is based on chromatographic separation of HbA1c on a cation exchange cartridge. The Bio-Rad D-10 Hemoglobin Ale Program is intended for the percent determination of hemoglobin A1 c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad D-10 Hemoglobin A1c Program is intended for Professional Use Only. The D-10 Hemoglobin A1c Program is for use only with the Bio-Rad D-10 Hemoglobin Testing System.

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc., Hercules, CA 4000 Alfred Nobel Dr Hercules CA 94547-1803·Product code LCP·September 8, 2010

    D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection and analysis.

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code LCP·February 27, 2014

    O-ARM 1000 IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·July 22, 2016

    PERI-GUARD

    FDA Adverse Event
    Injury ·BIO-VASCULAR, INC.·Product code MFX·December 6, 1997

    O-ARM 1000 IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 4, 2016

    O-ARM 1000 IMAGING SYSTEM 3RD EDITION

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 16, 2016

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·April 9, 2024

    O-ARM 1000 IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 10, 2016

    O-ARM 1000 IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 3, 2016

    4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate

    FDA Recall
    Terminated ·Greiner Bio-One North America, Inc.·Product code JKA·April 26, 2016

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·December 6, 2020

    CM DRIVE IMPLANT 4.3X11.5

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·February 22, 2019

    Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. Catalog Numbers: 270-2417 and 270-2415; Distributed and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA The Intended Use is as follows: The Bior-Rad II TURBO Hemoglobin A1c Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II. TURBO Hemoglobin Alc Program is intended for Professional Use Only--For In Vitro Diagnostic Use. Reagent Kit Information: The VARIANT II TURBO Hemoglobin A1c program utilizes principles of ionexchange high performance liquid chromatography (HPLC). The VARIANT II Hemoglobin A1c Program is based on chromatographic separation of HbAlc on a cation exchange cartridge. System Overview: The VARIANT II TURBO Hemoglobin testing System provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin Alc in EDTA human whole blood. Technology Overview: The V ARIANT II TURBO Hemoglobin Testing is a fully automated, high-throughput hemoglobin analyzer. It consists of two modules- the VARIANT II Chromatographic Station (VCS) and the VARIANT II Sampling Station (VSS). In addition, a personal computer is used to control the VARIANT II TURBO System using Clinical Data Management (CDM) software. CDM is a dedicated software package of instrument control, data control, results analysis, calibration, quality control and service software.

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code LCP·December 1, 2009

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·June 7, 2024

    REBAR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROVASCULAR·Product code KRA·December 4, 2018

    BIO-LOGIC NAVIGATOR PRO

    FDA Adverse Event
    Malfunction ·NATUS MEDICAL INC.·Product code GWF·November 12, 2013

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·September 20, 2023

    O-ARM 1000 IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·October 27, 2016