For in vitro diagnostic use. Others cobas liat CT NG MG IVD cobas® liat CT/NG/MG PID00000922 nucleic acid test 09 449 604 190 9 449 604 190 09449604190 9449604190 09449604190 KIT COBAS LIAT CT/NG/MG IVD KIT COBAS LIAT CT/NG/MG IVD 00875197007268 Reagents, kits 1 pack 20 tests true The cobas® liat CT/NG/MG nucleic acid test is an automated, qualitative in vitro nucleic acid diagnostic test that utilizes real- time polymerase chain reaction (PCR) for the direct detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG) nucleic acid in male urine and vaginal swabs, all in cobas® PCR Media (Roche Molecular Systems, Inc.).This test is intended as an aid in the diagnosis of urogenital infections in both symptomatic and asymptomatic individuals. en The test is performed on the cobas® liat analyzer which automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in biological samples using real-time PCR assays. The assay targets both the Cryptic plasmid and 23S rRNA of Chlamydia trachomatis, the pivNG and NGR9 of Neisseria gonorrhoeae, and the 23S rRNA and mgpC of Mycoplasma genitalium. An Internal Control (IC) is also included. The IC is present to control for adequate processing of the target bacteria through steps of sample purification, nucleic acid amplification, and to monitor thepresence of inhibitors in the PCR processes.The sample to result time is approximately 20 minutes. en

Instrument	cobas® liat system
Targets	Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma genitalium (MG)
Registration	FDA 510(k) cleared, CLIA-waived
Time to result	20 minutes
Sample type	Male urine, vaginal swabs (clinician collected and self-collected in a clinical setting)
Reagents	Ready-to-use, pre-packed tube format
Kit Storage	2–8°C
Collection media	cobas® PCR Media
Technology	Real-time PCR
Sample extraction	Fully automated and integrated
Control	Internal sample processing control, positive and negative controls

Material Number	Alternative Catalog Number	Material Description	Pack Size	Pack size Description
09449604190		KIT COBAS LIAT CT/NG/MG	1 pack	20 tests
09449639190		KIT COBAS LIAT CT/NG/MG QC	1 pack	3 sets
07958030190		cobas PCR Media Uni Swab Sample Kit	1 pack	100 uni swab sample packets
05170486190		COBAS PCR MEDIA URINE SAMPLE KIT	1 pack	100 Urine Sample Packets

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cobas^® liat CT/NG/MG

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cobas® liat CT/NG/MG specifications