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

General Purpose Reagent (PPM) (10)

Premarket Exempt

No Yes

Clear

IMMY - 00816387020940 Catalog Number :

Device Description : MycoDDR Prep Blue - 2.5%

Device Class :

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 10

IMMY - 00816387020964 Catalog Number :

Device Description : MycoDDR Prep Blue 3.0%

Device Class :

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 10

IMMY - 00816387020988 Catalog Number :

Device Description : MycoDDR 2.5% NaOH Reagent Kit

Device Class : 1

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 1

IMMY - 00816387020995 Catalog Number :

Device Description : MycoDDR 3.0% NaOH Reagent Kit

Device Class : 1

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 1

IMMY - 00816387021046 Catalog Number :

Device Description : 2.5% NaOH Reagent A

Device Class :

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 1

IMMY - 00816387021060 Catalog Number :

Device Description : 3.0% NaOH Reagent A

Device Class : 1

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 1

IMMY - 00816387021084 Catalog Number :

Device Description : NALC Powder

Device Class :

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 1

IMMY - 00816387021107 Catalog Number :

Device Description : MycoDDR Neutralization Buffer B

Device Class :

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 1

IMMY - 00816387021121 Catalog Number :

Device Description : MycoDDR Neutralization Buffer B

Device Class :

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 1

IMMY - 00816387021145 Catalog Number :

Device Description : MycoDDR Resuspension Buffer C

Device Class :

Duns Number: 099550915

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 1

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