Immuno-Mycologics, Inc.

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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

Antigens, Histoplasma Capsulatum, All (GMJ) (4) Antiserum, Positive Control, Histoplasma Capsulatum (GMK) (3) Reagents,Specific,Analyte (MVU) (3)

Premarket Exempt

No Yes

Clear

IMMY - 00816387020346 Catalog Number :

Device Description : Histoplasma Mycelial CF Antigen Dilute

Device Class : 2

Duns Number: 099550915

Premarket Exempt : No

Product Code : GMJ

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020353 Catalog Number :

Device Description : Histoplasma Mycelial CF Positive Control

Device Class : 2

Duns Number: 099550915

Premarket Exempt : No

Product Code : GMK

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020360 Catalog Number :

Device Description : Histoplasma Yeast CF Antigen Dilute

Device Class : 2

Duns Number: 099550915

Premarket Exempt : No

Product Code : GMJ

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020377 Catalog Number :

Device Description : Histoplasma Yeast CF Antigen Dilute

Device Class : 2

Duns Number: 099550915

Premarket Exempt : No

Product Code : GMJ

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020384 Catalog Number :

Device Description : Histoplasma Yeast CF Positive Control

Device Class : 2

Duns Number: 099550915

Premarket Exempt : No

Product Code : GMK

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020391 Catalog Number :

Device Description : Histoplasma ID Antigen

Device Class : 2

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : GMJ

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020407 Catalog Number :

Device Description : Histoplasma ID Positive Control

Device Class : 2

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : GMK

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020414 Catalog Number :

Device Description : 1000 EIA Unit Histoplasma Antigens

Device Class : 1

Duns Number: 099550915

Premarket Exempt : No

Product Code : MVU

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020421 Catalog Number :

Device Description : 100 ng/mL Histoplasma Galactomannan

Device Class : 1

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020438 Catalog Number :

Device Description : Diluted HRP Anti Histoplasma mAb 26-10 IgG

Device Class : 1

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : Yes

Device Count : 1

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