Hologic, Inc. PRD-05188 Aptima®

Aptima® CV/TV assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis.

Xpert Xpress MVP

Swab Specimen Collection Kit

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 the 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.

Aptima® BV Assay Controls Kit.

Aptima® BV assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima® BV assay is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA®) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae.

Aptima® BV assay, 100 test, box 1 of 2 (2°C to 8°C box). The Aptima® BV assay is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA®) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae.

Aptima® CV/TV Assay Calibrator.

Aptima® CV/TV Assay Controls Kit.

Aptima® CV/TV assay, 100 test, box 1 of 2 (2°C to 8°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis.

Aptima® CV/TV assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis.

Xpert Xpress MVP

Swab Specimen Collection Kit

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 the 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.