Address:200 Cooper Avenue North,Saint Cloud,MN,56303,US
Device Description : QC Sets and Panels: Helix Elite™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT QC Sets and Panels: Helix Elite™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No
Device Description : QC Sets and Panels: Helix Elite™ Group B Streptococcus (GBS) Control Panel (Inac QC Sets and Panels: Helix Elite™ Group B Streptococcus (GBS) 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 (4 Targets) Control Panel (Inactivated Swab)
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No
Device Description : QC Sets and Panels: Helix Elite™ Rifampicin-Resistant Mycobacterium tuberculosis QC Sets and Panels: Helix Elite™ Rifampicin-Resistant Mycobacterium tuberculosis Negative Control (Inactivated Pellet)
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No
Device Description : QC Sets and Panels: Helix Elite™ Rifampicin-Resistant Mycobacterium tuberculosis QC Sets and Panels: Helix Elite™ Rifampicin-Resistant Mycobacterium tuberculosis Positive Control Panel (Inactivated Pellet)
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No
Device Description : QC Sets and Panels: Helix Elite™ Mycoplasma genitalium Control Panel (Inactivated Pellet)
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No
Device Description : QC Sets and Panels: Helix Elite™ Gastrointestinal (22 Targets) Control Panel (In QC Sets and Panels: Helix Elite™ Gastrointestinal (22 Targets) Control Panel (Inactivated Pellet)
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No
Device Description : QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Control QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet)
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No
Device Description : QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Verific QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet)
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No
Device Description : QC Sets and Panels: KWIK-STIK™ Blood Culture Identification 2 (BCID2) Verificati QC Sets and Panels: KWIK-STIK™ Blood Culture Identification 2 (BCID2) Verification Panel (Live Culture)
Device Class : 1
Duns Number: 060467826
Premarket Exempt : Yes
Prescription Use : No