Address:200 Cooper Avenue North,Saint Cloud,MN,56303,US
Device Description : QC Sets and Panels: KWIK-STIK™ Cdiff Verification Panel (Live Culture)
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No
Device Description : QC Sets and Panels: Helix Elite™ Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab)
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No
Device Description : QC Sets and Panels: Helix Elite™ Respiratory Control Panel (22 Targets)
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No
Device Description : QC Sets and Panels: Helix Elite™ Pneumonia (33 Targets) Control Panel
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No
Device Description : QC Sets and Panels: Helix Elite™ Multiplex Vaginal Verification Panel
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No
Device Description : Helix Elite™ Molecular Standards Bacterial vaginosis (BV) Control Panel
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No
Device Description : Helix Elite™ Molecular Standards Candida vaginitis/Trichomonas vaginalis (CV/TV) Helix Elite™ Molecular Standards Candida vaginitis/Trichomonas vaginalis (CV/TV) Control Panel
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No
Device Description : Helix Elite™ Molecular Standards Blood Culture Identification Control Panel (43 Targets)
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No
Device Description : Helix Elite™ Molecular Standards Multiplex Vaginal Control Panel
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No
Device Description : QC Sets and Panels: Helix Elite™ Rapid Group B Streptococcus (GBS) Control Panel
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No