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, Aspergillus Spp. (JWT) (6) Antiserum, Positive Control, Aspergillus Spp. (KFG) (4)

Premarket Exempt

No Yes

Clear

IMMY - 00816387020001 Catalog Number :

Device Description : Aspergillus CF Antigen Dilute

Device Class : 1

Duns Number: 099550915

Premarket Exempt : No

Product Code : JWT

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020018 Catalog Number :

Device Description : Aspergillus CF Positive Control

Device Class : 1

Duns Number: 099550915

Premarket Exempt : No

Product Code : KFG

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020025 Catalog Number :

Device Description : Aspergillus ID Antigen

Device Class : 1

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : JWT

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020032 Catalog Number :

Device Description : Aspergillus ID Positive Control

Device Class : 1

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : KFG

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020049 Catalog Number :

Device Description : Aspergillus fumigatus ID Antigen

Device Class : 1

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : JWT

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020056 Catalog Number :

Device Description : Aspergillus fumigatus ID Positive Control

Device Class : 1

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : JWT

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020063 Catalog Number :

Device Description : Aspergillus flavus ID Antigen

Device Class : 1

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : JWT

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020070 Catalog Number :

Device Description : Aspergillus flavus ID Positive Control

Device Class : 1

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : KFG

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020087 Catalog Number :

Device Description : Aspergillus niger ID Antigen

Device Class : 1

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : JWT

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020094 Catalog Number :

Device Description : Aspergillus niger ID Positive Control

Device Class : 1

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : KFG

Prescription Use : Yes

Device Count : 1

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