BEUDAMED
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    The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacterial cells directly from a positive blood culture (PBC). The cartridge and instrument isolate and concentrate bacterial cells directly from PBC by removing blood, cellular and culture media matrix components from the sample, thereby reducing the sample volume considerably while maintaining bacterial cell viability. The resulting material is a purified microbial suspension or Liquid Colony for use in downstream in vitro diagnostics.

    FDA Enforcement
    Class II ·Ongoing·Qvella Corporation·December 14, 2022

    Bundle - Pilates Rehab Studio 1 (Mat/Reformer)

    Device
    EU MDR · Eu Md Class 1 ·Merrithew International Inc·On the market·21 countries

    Silicone Pin Mats

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Batrik Medical Manufacturing Inc.·2 devices

    Magnetic Silicone Mats

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Batrik Medical Manufacturing Inc.·2 devices

    Anti-Fatigue Mats

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Batrik Medical Manufacturing Inc.·24 devices