Gonochek®-II is intended for the use in the detection of prolyliminopeptidase, gammaglutamylaminopeptidase, and beta-galactosidase from colonies grown on selective media, to aid in the presumptive identification of Neisseria gonorrhoeae, Neisseria meningitidis, Neisseria lactamica and Moraxella (Branhamella) catarrhalis.Gonochek®-II consists of a reagent tube which contains three chromogenic substrates for use in the detection of three preformed enzymes, prolyliminopeptidase, gamma-glutamyl-aminopeptidase, and beta-galactosidase. These three enzymes have been shown to be accurate in identifying N.gonorrhoeae, N. meningitidis and N. lactamica respectively. The red cap of the Reagent Tube contains a color developer (diazo dye).
A collection of devices intended exclusively for professional use to collect a clinical specimen at the point-of-care for subsequent in vitro diagnostic investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis and human immunodeficiency virus (HIV)]. It consists of one or multiple transport containers, with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)], and sampling/collection tool(s) [e.g., vaginal, rectal or oropharyngeal swab, brush, spatula, lancet, pipette]. This is a single-use device.
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