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

PLATES, OUCHTERLONY AGAR (JZP) (4) Antiserum, Positive Control, Histoplasma Capsulatum (GMK) (2) CANDIDA SPECIES, ANTIBODY DETECTION (LSG) (2) Discs, strips and reagents, microorganism differentiation (JTO) (1) PROTEIN, COMPLEMENT, ANTIGEN, ANTISERUM, CONTROL (DHL) (1)

Premarket Exempt

No Yes

Clear

Fungal Serology - 10634853000114 Catalog Number : 200135

Device Description : Histoplasma capsulatum Antiserum (H&M), 2mL

Device Class : 2

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : GMK

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000121 Catalog Number : 200260

Device Description : Histoplasma capsulatum Antiserum, 1mL ID/EXO

Device Class : 2

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : GMK

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000138 Catalog Number : 200150-1

Device Description : Immunodiffusion Agar Plates, 1 - 7 Well Pattern

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JZP

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000145 Catalog Number : 200150-3

Device Description : Immunodiffusion Agar Plates, 3 - 7 Well Pattern

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JZP

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000152 Catalog Number : 200150-8

Device Description : Immunodiffusion Agar Plates, 8 - 7 Well Pattern

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JZP

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000169 Catalog Number : 200155

Device Description : Normal Rabbit Serum (Negative), 1mL

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : DHL

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000176 Catalog Number : 200160

Device Description : Clarifying Reagent (Sodium Citrate), 20mL

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000183 Catalog Number : 200165

Device Description : Immunodiffusion Agar, 12mL Deeps

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JZP

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000206 Catalog Number : 200180

Device Description : Candida Antigen, 1mL

Device Class : 2

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : LSG

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000213 Catalog Number : 200185

Device Description : Candida Antiserum, 2mL

Device Class : 2

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : LSG

Prescription Use : No

Device Count : 1

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