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) ANTIGEN, CF, ASPERGILLUS SPP. (JWT) (3) ANTISERUM, POSITIVE CONTROL, ASPERGILLUS SPP. (KFG) (3)

Premarket Exempt

No Yes

Clear

Fungal Serology - 10634853000220 Catalog Number : 200190

Device Description : Aspergillus flavus Antigen, 1mL

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JWT

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000237 Catalog Number : 200195

Device Description : Aspergillus fumigatus Antigen, 1mL

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JWT

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000244 Catalog Number : 200200

Device Description : Aspergillus niger Antigen, 1mL

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JWT

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000251 Catalog Number : 200205

Device Description : Aspergillus flavus Antiserum, 2mL

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : KFG

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000268 Catalog Number : 200210

Device Description : Aspergillus fumigatus Antiserum, 2mL

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : KFG

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000275 Catalog Number : 200215

Device Description : Aspergillus niger Antiserum, 2mL

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : KFG

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000299 Catalog Number : 200225-1

Device Description : Asp. 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 - 10634853000305 Catalog Number : 200225-3

Device Description : Asp. 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 - 10634853000312 Catalog Number : 200225-8

Device Description : Asp. 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 - 10634853000343 Catalog Number : 200225

Device Description : Asp. Immunodiffusion Agar, 12mL Deeps

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JZP

Prescription Use : No

Device Count : 1

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