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NATtrol™ BV Negative Control (NATBVNEG-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol BV Negative Control is a qualitative control containing intact and inactivated Lactobacillus crispatus and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert. NATtrol™ BV Positive Control (NATBVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol™ BV Positive Control is a qualitative control containing intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert. NATtrol™ Candida/TV Positive Control (NATCTVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol CandidaTV Positive Control is a qualitative control containing intact and inactivated Candida krusei, Candida glabrata, and Trichomonas vaginalis and intended to be used solely with the BD Vaginal Panel for the BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

NATtrol™ BD MAX Vaginal Panel External Controls are formulated with purified, intact microorganisms that have been chemically modified to render them non-infectious and refrigerator stable. The controls are formulated in a proprietary matrix that contains Fetal Bovine Serum, Human Serum Albumin, and sodium azide. NATtrol™ BV Positive Control contains intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence. NATtrol™ Candida/TV Positive Control contains intact and inactivated Candida albicans, Candida krusei, Candida glabrata, and Trichomonas vaginalis. NATtrol™ BV Negative Control contains intact and inactivated Lactobacillus crispatus.