Device Recall VIDAS Chlamydia kits

  • Model / Serial
    Catalog number: 30101-01, Lot number 868400501.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution- including CA, DC, FL, IL, IL, IN, MD, MI, MN, MO, MT, NC, NE, NJ, NY, PA, UT, VA and WI.
  • Product Description
    VIDAS Chlamydia test kits || VIDAS Chlamydia is an automated qualitative test for use on the VIDAS family instruments, for the detection of Chlamydia antigen in endocervical or urethral specimens, using the ELFA technique (Enzyme Linked Fluorescent Assay.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    bioMerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • Manufacturer Parent Company (2017)
  • Source
    USFDA