BEUDAMED
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    Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.

    FDA Enforcement
    Class II ·Terminated·Cook Vascular Inc.·April 4, 2018

    API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·April 30, 2014

    API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in the API Listeria strips. ZYM B reagent is added in the DIM test before reading miniaturized biochemical test including in the API Listeria strips.

    FDA Enforcement
    Class II ·Terminated·Biomerieux France Chemin De L'Or·February 5, 2014

    API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·April 30, 2014

    API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyping of Haemophilus influenza and Haemophilus parainfluenxzae, as well as the detection of a penicllinase.

    FDA Enforcement
    Class II ·Terminated·Biomerieux France Chemin De L'Or·February 5, 2014

    ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.

    FDA Enforcement
    Class II ·Terminated·Biomerieux France Chemin De L'Or·February 5, 2014

    FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·April 30, 2014

    ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·April 30, 2014

    AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5024543.

    FDA Enforcement
    Class II ·Terminated·Ab Sciex·September 17, 2014

    API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·February 10, 2016

    API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either automatically or manually and the identification is obtained using an identification software.

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·February 2, 2022

    XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT QUICK CONNECT USB, 41000-030-53; e) XSCRIBE CP KIT WIRELESS, 41000-030-60; f) XSCRIBE CP KIT WIRED, 41000-030-62; g) XSCRIBE CP SW KIT, 41000-030-64

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 17, 2024

    RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.

    FDA Enforcement
    Class II ·Terminated·Iris Diagnostics·December 31, 2014

    Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.

    FDA Enforcement
    Class II ·Terminated·Iris Diagnostics·May 22, 2013

    iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips.

    FDA Enforcement
    Class II ·Terminated·Iris Diagnostics·September 2, 2015

    API 50 CH, Model 50300

    FDA Enforcement
    Class II ·Terminated·bioMerieux, Inc.·November 24, 2021

    API JAMES 2AMP, CATALOG 70542

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023

    API NIT1 NIT2 REAGENTS, CATALOG 70442

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023

    API VP1 VP2 REAGENTS, CATALOG 70422

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023

    API 20 E 25 STRIPS, CATALOG 20100

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023