AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

FDA 510(k)

FDA Class 2 ·Microbiology

APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert CT/NG

FDA 510(k)

FDA Class 2 ·Microbiology

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

GEN-PROBE APTIMA COMBO 2 ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196

FDA 510(k)

FDA Class 2 ·Microbiology

LCX NEISSERIA GONORRHOEAE ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

GEN-PROBE APTIMA COMBO 2 ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

COBAS CT/NG V2.0 TEST

FDA 510(k)

FDA Class 2 ·Microbiology

GONOSTAT GONOCOCCAL DETECTION KIT

FDA 510(k)

FDA Class 2 ·Microbiology

cobas® CT/NG v2.0 Test

FDA 510(k)

FDA Class 2 ·Microbiology

XPERT CT/NG

FDA 510(k)

FDA Class 2 ·Microbiology

cobas CT/NG for use on cobas 6800/8800 systems

FDA 510(k)

FDA Class 2 ·Microbiology

HYBRID CAPTURE II CT/GC TEST

FDA 510(k)

FDA Class 2 ·Microbiology

TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

FDA 510(k)

FDA Class 2 ·Microbiology

TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS

FDA 510(k)

FDA Class 2 ·Microbiology

BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

cobas z 480 Analyzer

FDA registration

ROCHE MOLECULAR SYSTEMS, INC.·3 products·🇺🇸 United States