HARDY DIAGNOSTICS

Address:429 S Pioneer Blvd,Springboro,OH,45066,US

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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

Culture Media, Enriched (KZI) (1) Culture Media, Non-Selective And Differential (JSH) (1) Discs, Strips And Reagents, Microorganism Differentiation (JTO) (1)

Premarket Exempt

No Yes

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HardyDisk™ - 10816576028372 Catalog Number : Z7071

Device Description : Nitrate, HardyDisk™, for the determination of nitrate reduction by anaerobes, gr Nitrate, HardyDisk™, for the determination of nitrate reduction by anaerobes, gram negatives, 50 disks per cartridge, 1 eachFor the differentiation of anaerobes based on the ability to reduce nitrate

Device Class : 1

Duns Number: 039981550

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : No

Device Count : 50

N/A - 10819398028209 Catalog Number : A127

Device Description : Blood Agar 5%, 86x128mm Omni Tray, 30ml. Hardy Diagnostics Blood Agar products a Blood Agar 5%, 86x128mm Omni Tray, 30ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms.

Device Class : 1

Duns Number: 039981550

Premarket Exempt : Yes

Product Code : KZI

Prescription Use : No

Device Count : 10

HardyCHROM - 10819398028421 Catalog Number : G315

Device Description : HardyCHROM™ Sakazakii, 15x100mm Plate, 18ml. HardyCHROM™ Sakazakii is a chromoge HardyCHROM™ Sakazakii, 15x100mm Plate, 18ml. HardyCHROM™ Sakazakii is a chromogenic medium recommended for the selective isolation and differentiation of Cronobacter (Enterobacter) sakazakii from other members of the family Enterobacteriaceae based on colony color.

Device Class : 1

Duns Number: 039981550

Premarket Exempt : Yes

Product Code : JSH

Prescription Use : No

Device Count : 10

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