BD ProbeTec" CT/GC/AC Reagent Pack

Lot 0158908 exp May 31, 2011 and Lot 0158969 exp May 31, 2011

Immunology and Microbiology Devices

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Worldwide Distribution--USA (nationwide) including the states of AL, CA, CO, CT, FL, GA, KY, LA, ME, MN, MO, MS, MT, NE, OH, PA, RI, TX, and WA and the countries of Australia, Canada, Europe, and Japan.

BD ProbeTec" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152*** || The BD ProbeTec" ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays, when tested with the BD ProbeTec ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with both C. trachomatis and N. gonorrhoeae. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper" instrument.