Hardy Diagnostics

3 devices in the database

  • Model / Serial
    All units manufactured between October 2014 and May 2016.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    U.S. Distribution to the following states: CA, TX, NE, OK, LA, NC, PA, AZ, NY, PA, VA, NM, MI, and WV.
  • Product Description
    QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. || Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
  • Model / Serial
    Lot H16054 and H15056.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.
  • Product Description
    Hardy Diagnostics GBS Detect || Cat no. A300. || Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
  • Model / Serial
    Cat. no. K31 Lot no.15231
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US. Distribution to the states of : CA, WI, MD and UT. .
  • Product Description
    FB Broth, 10ml || (Fastidious Bacteria Broth) || Cat. no: K31 Lot: 15231 || A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.

One manufacturer with a similar name

Learn more about the data here

  • Manufacturer Address
    Hardy Diagnostics, 1430 W Mccoy Ln, Santa Maria CA 93455-1005
  • Manufacturer Parent Company (2017)
  • Source
    USFDA