A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of CD4 cell marker in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immun...
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 gonorrhoe...
A collection of devices intended to be used by a layperson in the home to collect a clinical specimen for subsequent in vitro diagnostic investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas ...
A collection of devices intended to be used to collect a clinical specimen at the point-of-care for subsequent laboratory analysis and/or other investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trich...