Device Description : The NATtrol™ Staphylococcus aureus (SA) Positive Control is an unassayed in vitr The NATtrol™ Staphylococcus aureus (SA) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. 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 errors. NATtrol™ SA Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
Device Class : 1
Duns Number: 184020902
Premarket Exempt : Yes
Prescription Use : No
Device Description : NATtrol™ BV Positive Control (NATBVPOS-BD) is intended for use as an assayed qua 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.
Device Class : 2
Duns Number: 081586435
Premarket Exempt : No
Prescription Use : Yes
Device Description : NATtrol™ BV Negative Control (NATBVNEG-BD) is intended for use as an assayed qua 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 the 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.
Device Class : 2
Duns Number: 081586435
Premarket Exempt : No
Prescription Use : Yes
Device Description : NATtrol™ Candida/TV Positive Control (NATCTVPOS-BD) is intended for use as an as 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 Candida/TV Positive Control is a qualitative control containing intact and inactivated Candida albicans, 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.
Device Class : 2
Duns Number: 081586435
Premarket Exempt : No
Prescription Use : Yes
Device Description : NATCT(434)-6MC is a qualitative in vitro diagnostic external run control intende NATCT(434)-6MC is a qualitative in vitro diagnostic external run control intended to be used with molecular assays.
Device Class : 1
Duns Number: 081586435
Premarket Exempt : Yes
Prescription Use : No
Device Description : NATNG-6MC is a qualitative in vitro diagnostic external run control intended to NATNG-6MC is a qualitative in vitro diagnostic external run control intended to be used with molecular assays.
Device Class : 1
Duns Number: 081586435
Premarket Exempt : Yes
Prescription Use : No
Device Description : NATCTNGNEG-6MC is a qualitative in vitro diagnostic external run control intende NATCTNGNEG-6MC is a qualitative in vitro diagnostic external run control intended to be used with molecular assays.
Device Class : 1
Duns Number: 081586435
Premarket Exempt : Yes
Prescription Use : No
Device Description : NATtrol™ Vaginal Positive Control (NATVPOS-6C) is a qualitative in vitro diagnos NATtrol™ Vaginal Positive Control (NATVPOS-6C) is a qualitative in vitro diagnostic control intended to be used with molecular assays for the detection of Atopobium vaginae, BVAB2, Candida albicans, Candida glabrata, and Trichomonas vaginalis for the evaluation of test performance.
Device Class : 1
Duns Number: 081586435
Premarket Exempt : Yes
Prescription Use : No
Device Description : NATtrol™ Vaginal Negative Control (NATVNEG-6C) is a qualitative in vitro diagnos NATtrol™ Vaginal Negative Control (NATVNEG-6C) is a qualitative in vitro diagnostic control intended to be used with molecular assays for the detection of Atopobium vaginae, BVAB2, Candida albicans, Candida glabrata, and Trichomonas vaginalis for the evaluation of test performance.
Device Class : 1
Duns Number: 081586435
Premarket Exempt : Yes
Prescription Use : No
Device Description : NATtrol™ Vaginal Bundle contains qualitative in vitro diagnostic controls, NATtr NATtrol™ Vaginal Bundle contains qualitative in vitro diagnostic controls, NATtrol Vaginal Positive Control (NATVPOS-6C) DI number 01220000260290, and NATtrol Vaginal Negative Control (NATVNEG-6C) DI number 01220000260306, which are intended to be used with molecular assays for the detection of Atopobium vaginae, BVAB2, Candida albicans, Candida glabrata, and Trichomonas vaginalis for the evaluation of test performance.
Device Class : 1
Duns Number: 081586435
Premarket Exempt : Yes
Prescription Use : No