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

Antigen, Cf And/Or Id, Coccidioides Immitis (GMI) (2) Antisera, Latex Agglutination, Cryptococcus Neoformans (GMD) (2) Antiserum, Positive Control, Coccidioides Immitis (GMH) (2) Candida Species, Antibody Detection (LSG) (2) Antigens, Histoplasma Capsulatum, All (GMJ) (1) Reagents,Specific,Analyte (MVU) (1)

Premarket Exempt

No Yes

Clear

IMMY - 00816387020209 Catalog Number :

Device Description : Coccidioides IDCF Antigen

Device Class : 2

Duns Number: 099550915

Premarket Exempt : No

Product Code : GMI

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020216 Catalog Number :

Device Description : Coccidioides IDCF Positive Control

Device Class : 2

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : GMH

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020223 Catalog Number :

Device Description : Candida ID Antigen

Device Class : 2

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : LSG

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020230 Catalog Number :

Device Description : Candida ID Positive Control

Device Class : 2

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : LSG

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020247 Catalog Number :

Device Description : Coccidioides IDTP Antigen

Device Class : 2

Duns Number: 099550915

Premarket Exempt : No

Product Code : GMI

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020261 Catalog Number :

Device Description : Cryptococcus Antigen External Positive Control

Device Class : 1

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020278 Catalog Number :

Device Description : Coccidioides IDTP Positive Control

Device Class : 2

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : GMH

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020292 Catalog Number :

Device Description : LF Titration Diluent

Device Class : 2

Duns Number: 099550915

Premarket Exempt : No

Product Code : GMD

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020322 Catalog Number :

Device Description : Lateral Flow Specimen Diluent

Device Class : 2

Duns Number: 099550915

Premarket Exempt : No

Product Code : GMD

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020339 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

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