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

Stains, microbiologic (JTS) (4) ANTISERUM, POSITIVE CONTROL, ASPERGILLUS SPP. (KFG) (3) ANTIGEN, CF, ASPERGILLUS SPP. (JWT) (2) Kit, quality control for culture media (JTR) (1)

Premarket Exempt

No Yes

Clear

Fungal Serology - 10634853000398 Catalog Number : 200280

Device Description : Aspergillus terreus Antiserum, 2mL

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : KFG

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000404 Catalog Number : 200285

Device Description : Aspergillus nidulans Antigen, 1mL

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JWT

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000411 Catalog Number : 200290

Device Description : Aspergillus nidulans Antiserum, 2mL

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : KFG

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000428 Catalog Number : 200345

Device Description : Aspergillus Pooled Antigen, 1mL

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JWT

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000435 Catalog Number : 200350

Device Description : Aspergillus Pooled Antiserum, 2mL

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : KFG

Prescription Use : No

Device Count : 1

India Ink - 10634853000480 Catalog Number : 100111

Device Description : India Ink, Positive Control

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTS

Prescription Use : No

Device Count : 1

India Ink - 10634853000497 Catalog Number : 100112

Device Description : India Ink, Negative Control

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTS

Prescription Use : No

Device Count : 1

India Ink - 10634853000503 Catalog Number : 100114

Device Description : India Ink

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTS

Prescription Use : No

Device Count : 1

India Ink - 10634853000510 Catalog Number : 100115

Device Description : India Ink Kit

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTS

Prescription Use : No

Device Count : 1

Microorganism Pellets - 10634853000589 Catalog Number : URI-KIT

Device Description : Culture Control Kit for Uricult

Device Class : 1

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JTR

Prescription Use : No

Device Count : 1

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