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

Antigen, Cf And/Or Id, Coccidioides Immitis (GMI) (2) Antigen, Cf, B. Dermatitidis (JWW) (2) Antigens, Histoplasma Capsulatum, All (GMJ) (2) Antiserum, Blastomyces Dermatitidis, Other (LSI) (2) Antiserum, Positive Control, Coccidioides Immitis (GMH) (2)

Premarket Exempt

No Yes

Clear

Fungal Serology - 10634853000015 Catalog Number : 200125

Device Description : Blastomyces dermatitidis Antigen (A), 1mL

Device Class : 2

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JWW

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000022 Catalog Number : 200250

Device Description : Blastomyces dermatitidis Antigen (A), 2mL ID/EXO

Device Class : 2

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : JWW

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000039 Catalog Number : 200265

Device Description : Blastomyces dermatitidis Antiserum, 1mL ID/EXO

Device Class : 2

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : LSI

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000046 Catalog Number : 200140

Device Description : Blastomyces dermatitidis Antiserum, 2mL

Device Class : 2

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : LSI

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000053 Catalog Number : 200130

Device Description : Coccidioides immitis Antigen (F), 1mL

Device Class : 2

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : GMI

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000060 Catalog Number : 200255

Device Description : Coccidioides immitis Antigen (HS), 2mL ID/EXO

Device Class : 2

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : GMI

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000077 Catalog Number : 200145

Device Description : Coccidioides immitis Antiserum (F), 2mL

Device Class : 2

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : GMH

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000084 Catalog Number : 200270

Device Description : Coccidioides immitis Antiserum (HS), ID/EXO

Device Class : 2

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : GMH

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000091 Catalog Number : 200120

Device Description : Histoplasma capsulatum Antigen (H&M), 1mL

Device Class : 2

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : GMJ

Prescription Use : No

Device Count : 1

Fungal Serology - 10634853000107 Catalog Number : 200245

Device Description : Histoplasma capsulatum Antigen (H&M), 2mL ID/EXO

Device Class : 2

Duns Number: 060467826

Premarket Exempt : Yes

Product Code : GMJ

Prescription Use : No

Device Count : 1

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