MICROBIOLOGICS INC.

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

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Filters

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) (4) Discs, strips and reagents, microorganism differentiation (JTO) (2) Kit, quality control for culture media (JTR) (2) Calibrator, secondary (JIT) (1) KIT, QUALITY CONTROL FOR CULTURE MEDIA (JTR) (1)

Premarket Exempt

No Yes

Clear

Inocu Swabs - 10634853001296 Catalog Number : MRSA-02

Device Description : MRSA Negative

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTR

Prescription Use : No

Device Count : 1

Inocu Swabs - 10634853001302 Catalog Number : MSSE-01

Device Description : MSSE Negative Control

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTR

Prescription Use : No

Device Count : 1

Test Kits - 10634853001340 Catalog Number : 60060

Device Description : ID-AE KIT

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : No

Device Count : 1

Test Kits - 10634853001357 Catalog Number : 60500

Device Description : Oxidase Swabs

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : No

Device Count : 1

Tri-Valent™ Swab - 10634853001364 Catalog Number : CV-01

Device Description : Vaginitis Calibration Panel

Device Class : 2

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Tri-Valent™ Swab - 10634853001388 Catalog Number : TVS-01

Device Description : Tri-Valent Positive Control Swab

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Tri-Valent™ Swab - 10634853001395 Catalog Number : TVS-02

Device Description : Tri-Valent Negative Control Swab

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Tri-Valent™ Swab - 10634853001401 Catalog Number : VP-03

Device Description : Trichomonas Verification Set

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Tri-Valent™ Swab - 10634853001418 Catalog Number : VV-01

Device Description : Vaginitis Validation Panel

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

KWIK-STIK™ - 10845357000047 Catalog Number : 0101U

Device Description : KWIK-STIK™ S. zooepidemicus ATCC 43079™

Device Class :

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTR

Prescription Use : No

Device Count : 1

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