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) (2) Multi-Analyte Controls Unassayed (OHQ) (2) Antigen, Elisa, Cryptococcus (MDU) (1) Antigen, Blastomyces Dermatitidis, Other (LSH) (1) Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum (MIZ) (1) Enzyme Linked Immunosorbent Assay, Coccidioides Immitis (MIY) (1) Eia, Blastomyces Dermatitidis (MJL) (1) Antigen, Cf And/Or Id, Coccidioides Immitis (GMI) (1)

Premarket Exempt

No Yes

Clear

IMMY - 00816387020445 Catalog Number :

Device Description : Histoplasma Galactomannan Negative Control

Device Class : 1

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020452 Catalog Number :

Device Description : Histoplasma Galactomannan Positive Control

Device Class : 1

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020575 Catalog Number :

Device Description : Blastomyces CF Antigen

Device Class : 2

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : LSH

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020582 Catalog Number :

Device Description : Coccidioides CF Antigen

Device Class : 2

Duns Number: 099550915

Premarket Exempt : No

Product Code : GMI

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020599 Catalog Number :

Device Description : Histoplasma Mycelial CF Antigen

Device Class : 2

Duns Number: 099550915

Premarket Exempt : No

Product Code : GMJ

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020605 Catalog Number :

Device Description : Histoplasma Yeast CF Antigen

Device Class : 2

Duns Number: 099550915

Premarket Exempt : No

Product Code : GMJ

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020704 Catalog Number :

Device Description : OMEGA Blastomyces Total Antibody EIA

Device Class :

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : MJL

Prescription Use : Yes

Device Count : 96

IMMY - 00816387020728 Catalog Number :

Device Description : OMEGA Coccidioides Antibody EIA

Device Class :

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : MIY

Prescription Use : Yes

Device Count : 96

IMMY - 00816387020759 Catalog Number :

Device Description : Cryptococcus Antigen EIA

Device Class :

Duns Number: 099550915

Premarket Exempt : No

Product Code : MDU

Prescription Use : Yes

Device Count : 96

IMMY - 00816387020773 Catalog Number :

Device Description : ALPHA Histoplasma Antigen EIA

Device Class :

Duns Number: 099550915

Premarket Exempt : No

Product Code : MIZ

Prescription Use : Yes

Device Count : 96

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