NATtrol™ Neisseria gonorrhoeae Positive Control Pack (IVD)MDZ003
PRODUCT DESCRIPTION: NATtrol™ Neisseria gonorrhoeae (Strain Z017) Positive Controls are formulated with purified, intact organisms that have been chemically modified to render them non-infectious and refrigerator stable*. Each NATtrol™ Neisseria gonorrhoeae Positive Control Pack contains 6 x 1.25 mL vials of NATtrolTM Neisseria gonorrhoeae formulated in a Purified Protein Matrix that is fully commutable with true clinical specimens. *NATtrol™ Patents Pending
INTENDED USE: NATtrol™ Neisseria gonorrhoeae Positive Controls are class 1 exempt, unassayed, in vitro, diagnostic external run controls intended for use with qualitative molecular assays. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic error. NATtrol™ Neisseria gonorrhoeae Positive Controls contain intact organisms and should be run in a manner identical to that used for clinical specimens.