MICROBIOLOGICS INC.

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

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Multi-analyte controls unassayed (OHQ) (7) Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays (PMN) (3)

Premarket Exempt

No Yes

Clear

QC Sets and Panels: Helix Elite™ - 70845357041240 Catalog Number : 8199

Device Description : Cepheid Xpert® Respiratory Control Panel

Device Class : 2

Duns Number: 060467826

Premarket Exempt : No

Product Code : PMN

Prescription Use : Yes

Device Count : 1

QC Sets and Panels: Helix Elite™ - 70845357041318 Catalog Number : 8208

Device Description : QC Sets and Panels: Helix Elite™ Vaginal Verification Panel

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

QC Sets and Panels: Helix Elite™ - 70845357041325 Catalog Number : 8209

Device Description : QC Sets and Panels: Helix Elite™ Vaginal Control Panel

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

QC Sets and Panels: Helix Elite™ - 70845357041356 Catalog Number : 8182

Device Description : QC Sets and Panels: Helix Elite™ Enteric Parasite Verification Panel (Synthetic)

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

QC Sets and Panels: Helix Elite™ - 70845357041363 Catalog Number : 8191

Device Description : QC Sets and Panels: Helix Elite™ Extended Enteric Bacterial Verification Panel ( QC Sets and Panels: Helix Elite™ Extended Enteric Bacterial Verification Panel (Inactivated Pellet)

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

QC Sets and Panels: Helix Elite™ - 70845357041370 Catalog Number : 8200

Device Description : Cepheid Xpert® C. difficile/Epi Control Panel

Device Class : 2

Duns Number: 060467826

Premarket Exempt : No

Product Code : PMN

Prescription Use : Yes

Device Count : 1

QC Sets and Panels: Helix Elite™ - 70845357041387 Catalog Number : 8203

Device Description : QC Sets and Panels: Helix Elite™ Vancomycin Resistant Enterococcus (VRE) Control QC Sets and Panels: Helix Elite™ Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

QC Sets and Panels: Helix Elite™ - 70845357041394 Catalog Number : 8204

Device Description : BD MAX™ Enteric Parasite Control Panel

Device Class : 2

Duns Number: 060467826

Premarket Exempt : No

Product Code : PMN

Prescription Use : Yes

Device Count : 1

QC Sets and Panels: Helix Elite™ - 70845357041400 Catalog Number : 8205

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

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

QC Sets and Panels: Helix Elite™ - 70845357041424 Catalog Number : 8180

Device Description : QC Sets and Panels: Helix Elite™ Gram-Positive Blood Culture Control Panel (Inac QC Sets and Panels: Helix Elite™ Gram-Positive Blood Culture Control Panel (Inactivated Pellet)

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

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