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, Blastomyces Dermatitidis, Other (LSH) (3) Antigen, Cf And/Or Id, Coccidioides Immitis (GMI) (2) Antiserum, Blastomyces Dermatitidis, Other (LSI) (2) Antigen, Cf, Aspergillus Spp. (JWT) (1) Antiserum, Positive Control, Aspergillus Spp. (KFG) (1) Antiserum, Positive Control, Coccidioides Immitis (GMH) (1)

Premarket Exempt

No Yes

Clear

IMMY - 00816387020100 Catalog Number :

Device Description : Aspergillus terreus ID Antigen

Device Class : 1

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : JWT

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020117 Catalog Number :

Device Description : Aspergillus terreus ID Positive Control

Device Class : 1

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : KFG

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020124 Catalog Number :

Device Description : Blastomyces CF Antigen Dilute

Device Class : 2

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : LSH

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020131 Catalog Number :

Device Description : Blastomyces CF Antigen Dilute

Device Class : 2

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : LSH

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020148 Catalog Number :

Device Description : Blastomyces CF Positive Control

Device Class : 2

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : LSI

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020155 Catalog Number :

Device Description : Blastomyces ID Antigen

Device Class : 2

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : LSH

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020162 Catalog Number :

Device Description : Blastomyces ID Positive Control

Device Class : 2

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : LSI

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020179 Catalog Number :

Device Description : Coccidioides CF Antigen Dilute

Device Class : 2

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : GMI

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020186 Catalog Number :

Device Description : Coccidioides CF Antigen Dilute

Device Class : 2

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : GMI

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020193 Catalog Number :

Device Description : Coccidioides CF Positive Control

Device Class : 2

Duns Number: 099550915

Premarket Exempt : No

Product Code : GMH

Prescription Use : Yes

Device Count : 1

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