Devices

VIDAS FSH

  • Model / Serial
    Lot #1005888210 was distributed in the U.S.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.
  • Product Description
    VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, 376, Chemin de l'Orme, 69280 March-l'Etoile - France. || Intended 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.
  • Manufacturer
    BioMerieux SA
  • 1 Event

Manufacturer

BioMerieux SA
  • Manufacturer Address
    BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
  • Manufacturer Parent Company (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA

9 devices with a similar name

Learn more about the data here

vidas fsh
  • Model / Serial
  • Product Description
    ivd
  • Manufacturer
    BIOMERIEUX
Vidas FSH
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX
VIDAS FSH, reference 30407
  • Model / Serial
  • Manufacturer
    N/A
VIDAS FSH Ref. 30407 / 30407-01
VIDAS FSH
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