BEUDAMED
    212 results · 29ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280 Marcy-l'Etoile - France - Product Usage: to be used for the release of total nucleic acid from biological specimens.

    FDA Enforcement
    Class II ·Terminated·BIOMERIEUX - Grenoble·March 4, 2020

    BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code MDB·December 25, 2012

    VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human follicle stimulating hormone (FSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of pituitary gland and gonadal disorders.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·July 4, 2018

    VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC and bioMerieux sa, France.

    FDA Recall
    Terminated ·bioMerieux Inc·Product code LON·January 15, 2004

    VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use - each test card is packaged into a foil pouch with 20 pouches per box. The firm name on the label is bioMerieux, Inc., Durham, NC and bioMerieux, sa, France.This is an Export Only test kit that is not marketed in the U.S.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·July 29, 2010

    VITEK 2 Gram Negative Susceptibility Card, AST-N172, REF 410 298, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010

    VITEK 2 Gram Negative Susceptibility Card, AST-N090, REF 22 240, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010

    VITEK 2 Gram Negative Susceptibility Card, AST-GN35, REF 22 286, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010

    VITEK 2 Gram Negative Susceptibility Card, AST-GN43, REF 410 759, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010

    VITEK 2 Gram Negative Susceptibility Card, AST-N137, REF 22 324, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010

    VITEK 2 Gram Negative Susceptibility Card, AST-N155, REF 22 352, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010

    VITEK 2 Gram Negative Susceptibility Card, AST-N093, REF 22 243, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010

    VITEK 2 Gram Negative Susceptibility Card, AST-N116, REF 22 289, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010

    VITEK 2 Gram Negative Susceptibility Card, AST-N167, REF 410 138, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010

    VITEK 2 Gram Negative Susceptibility Card, AST-N086, REF 22 234, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010

    VITEK 2 Gram Negative Susceptibility Card, AST-N106, REF 22 264, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010

    VITEK 2 Gram Negative Susceptibility Card, AST-N132, REF 22 316, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010

    VITEK 2 Gram Negative Susceptibility Card, AST-N171, REF 410 249, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010

    VITEK 2 Gram Negative Susceptibility Card, AST-N158, REF 22 355, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010

    VITEK 2 Gram Negative Susceptibility Card, AST-N163, REF 410 084, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010