MICROBIOLOGICS INC.

Address:200 Cooper Avenue North,Saint Cloud,MN,56303,US

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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

Product Code : OHQ

Prescription Use : No

Device Count : 1

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

Product Code : OHQ

Prescription Use : No

Device Count : 1

Device Description : QC Sets and Panels: Helix Elite™ Respiratory (4 Targets) Control Panel (Inactivated Swab)

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

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

Product Code : OHQ

Prescription Use : No

Device Count : 1

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

Product Code : OHQ

Prescription Use : No

Device Count : 1

Device Description : QC Sets and Panels: Helix Elite™ Mycoplasma genitalium Control Panel (Inactivated Pellet)

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

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

Product Code : OHQ

Prescription Use : No

Device Count : 1

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

Product Code : OHQ

Prescription Use : No

Device Count : 1

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

Product Code : OHQ

Prescription Use : No

Device Count : 1

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

Product Code : OHQ

Prescription Use : No

Device Count : 1