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

KIT, QUALITY CONTROL FOR CULTURE MEDIA (JTR) (3) Multi-Analyte Controls Unassayed (OHQ) (1) Multi-analyte controls unassayed (OHQ) (1)

Premarket Exempt

No Yes

Clear

QC Sets and Panels: Helix Elite™ - 70845357044197 Catalog Number : 8258

Device Description : QC Sets and Panels: Helix Elite™ Rapid Group B Streptococcus (GBS) Verification Panel

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

KWIK-STIK™ - 80845357041643 Catalog Number : 0864UE3

Device Description : KWIK-STIK™ S. agalactiae ATCC 12401™

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTR

Prescription Use : No

Device Count : 1

KWIK-STIK™ - 80845357041650 Catalog Number : 0864UE5

Device Description : KWIK-STIK™ S. agalactiae ATCC 12401™

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTR

Prescription Use : No

Device Count : 1

KWIK-STIK™ - 80845357041667 Catalog Number : 0864UE7

Device Description : KWIK-STIK™ S. agalactiae ATCC 12401™

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTR

Prescription Use : No

Device Count : 1

QC Sets and Panels: Helix Elite™ - 80845357043708 Catalog Number : ABT-001

Device Description : QC Sets and Panels: Helix Elite™ SARS-CoV-2 Verification Panel

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

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