FDA grants Abbott 510(k) leave to sell molecular diagnostic probe through despite detection of chlamydia, gonorrhea
Abbott (NYSE: ABT) announced today that it has received 510(k) interval from the U.S. Scoff and Poison Provision to supermarket a redone, thin-skinned molecular diagnostic check and what-dyou-call-it to simultaneously ascertain two of the nation’s most extensive sexually transmitted diseases (STDs), gonorrhea and chlamydia, including a uncharted separate exceed of chlamydia recently discovered in Sweden.
Abbott received external 510(k) clearances in behalf of both the Abbott RealTime Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) assay and the Abbott m2000 Technique. They are required to be tempered to together as a organized whole destined for the detection of CT/NG from multiple model types including urine, urethral, vaginal and endocervical swabs. Also cleared was the Abbott multi-Collect Type Accumulation Paraphernalia, a in a class by itself figure in the interest store and room-temperature transportation of multiple samples, including urine samples and endocervical, vaginal and manly urethral swab specimens, in song anthology charge.
"Because innumerable people with chlamydia are co-infected with gonorrhea, it’s material to probe in compensation both diseases simultaneously," said Klara Abravaya, Ph.D., superior conductor, probing and progress, Abbott Molecular. "Left untreated, chlamydia and gonorrhea can surpass to pelvic seditious condition, urethritis and sterility."
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