Abbott Receives 510(k) Clearance For CT/NG Assay And Abbott m2000 System

Abbott has received 510(k) clearance from the U.S. Food and Drug Administration to market a new, sensitive molecular diagnostic test and instrument to simultaneously detect two of the nation’s most prevalent sexually transmitted diseases (STDs), gonorrhea and chlamydia, including a new variant strain of chlamydia recently discovered in Sweden. Abbott received independent 510(k) clearances for both the Abbott RealTime Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) assay and the Abbott m2000 System.

Abbott Gets FDA Clearance For Molecular Diagnostic Test For Detection Of Chlamydia And Gonorrhea Infections

abbottAbbott has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market a new, sensitive molecular diagnostic test and instrument to simultaneously detect two of the nation’s most prevalent sexually transmitted diseases (STDs), gonorrhea and chlamydia, including a new variant strain of chlamydia recently discovered in Sweden. Abbott received independent 510(k) clearances for both the Abbott RealTime Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) assay and the Abbott m2000 System.

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