BEUDAMED
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    ADVIA CENTAUR TROPONIN ULTRA (TNI ULTRA) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·August 21, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554WWH

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 23, 2020

    MS IGG2A ISOTYPE CONTROL APC X39 ASR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MVU·December 31, 2020

    Antisera, C. Acnes

    FDA classification
    FDA Class 1 ·Antisera, C. Acnes

    KLI CORP.

    FDA registration
    KLI CORP.·1 product·🇺🇸 United States

    PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of containing Influenza A virus RNA. PS-MTM is also intended for the stabilization, transportation, and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis (MTB) DNA from human samples.

    FDA Enforcement
    Class II ·Ongoing·LONGHORN VACCINES AND DIAGNOSTIC·September 23, 2020

    KLM LABORATORIES, INC.

    FDA registration
    KLM LABORATORIES, INC.·1 product·🇺🇸 United States

    KLC SERVICES, INC./REEP

    FDA registration
    KLC SERVICES, INC./REEP·1 product·🇺🇸 United States

    PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of containing Influenza A virus RNA. PS-MTM is also intended for the stabilization, transportation, and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis (MTB) DNA from human samples.

    FDA Recall
    Open, Classified ·LONGHORN VACCINES AND DIAGNOSTIC 2 Bethesda Metro Cente·Product code QBD·June 3, 2020

    COULTER® LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·May 1, 2011

    IMMULITE HLH

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OPUS HLH

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OPUS HLH CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    QUANTIMUNE HLH RIA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIPLOMAT

    FDA UDI
    SIGNUS Medizintechnik GmbH·04047844121764·An orthopedic manual surgical instrument is a n...

    DIPLOMAT

    FDA UDI
    SIGNUS Medizintechnik GmbH·04047844121757·An orthopedic manual surgical instrument is a n...

    DIPLOMAT

    FDA UDI
    SIGNUS Medizintechnik GmbH·04047844121740·An orthopedic manual surgical instrument is a n...

    Lumipulse G LH Calibrators

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DELFIA TM HLH KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AFFINITY HLH TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry