Device Recall Abbott RealTime CT/NG Assay

  • Model / Serial
    All in date lots
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Abbott RealTime CT/NG Assay, List 8L07, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA || The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA for C. trachomatis and the genomic DNA of N. gonorrhoeae in female endocervical or vaginal swab specimens, male urethral swab specimens, or in male and female urine specimens.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Abbott Molecular, 1300 E Touhy Ave, Des Plaines IL 60018-3315
  • Source
    USFDA