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

Kit, quality control for culture media (JTR) (7) Discs, strips and reagents, microorganism differentiation (JTO) (3)

Premarket Exempt

No Yes

Clear

Chemmette Reagents - 10634853000633 Catalog Number : 300145

Device Description : Potassium Hydroxide (KOH 10%) Chemette

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : No

Device Count : 1

Chemmette Reagents - 10634853000725 Catalog Number : 300195

Device Description : Catalase Reagent Chemette

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : No

Device Count : 1

General Reagents - 10634853000848 Catalog Number : 60015

Device Description : Potassium Hydroxide (KOH 10%) 50mL

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : No

Device Count : 1

Inocu Swabs - 10634853001203 Catalog Number : CE VRE-01

Device Description : VRE Positive (Van A)

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTR

Prescription Use : No

Device Count : 1

Inocu Swabs - 10634853001210 Catalog Number : CE VRE-02

Device Description : VRE Negative

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTR

Prescription Use : No

Device Count : 1

Inocu Swabs - 10634853001227 Catalog Number : CE VRE-03

Device Description : VRE Positive (Van B)

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTR

Prescription Use : No

Device Count : 1

Inocu Swabs - 10634853001258 Catalog Number : CTGC-VP

Device Description : CT/GC Swab Validation Set (Chlamydia/GC)

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTR

Prescription Use : No

Device Count : 1

Inocu Swabs - 10634853001265 Catalog Number : GBS-01

Device Description : Group B Strep Positive

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTR

Prescription Use : No

Device Count : 1

Inocu Swabs - 10634853001272 Catalog Number : GBS-02

Device Description : Group B Strep Negative

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTR

Prescription Use : No

Device Count : 1

Inocu Swabs - 10634853001289 Catalog Number : MRSA-01

Device Description : MRSA Positive

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTR

Prescription Use : No

Device Count : 1

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