HARDY DIAGNOSTICS

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

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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

Culture Media, For Isolation Of Pathogenic Neisseria (JTY) (4) Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (JSO) (3) Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth (JTZ) (3)

Premarket Exempt

No Yes

Clear

NA - 00816576020010 Catalog Number : G45

Device Description : MUELLER HINTON AGARFor disk diffusion sensitivity testing of non-fastidious bacteria.

Device Class :

Duns Number: 039981550

Premarket Exempt : No

Product Code : JTZ

Prescription Use : Yes

Device Count : 10

NA - 00816576020027 Catalog Number : A59

Device Description : MUELLER HINTON with BLOOD(Mueller Hinton Agar with 5% Sheep Blood) For disk diff

Device Class :

Duns Number: 039981550

Premarket Exempt : No

Product Code : JTZ

Prescription Use : Yes

Device Count : 10

NA - 00816576020034 Catalog Number : E20

Device Description : MUELLER HINTON with CHOCOLATE(Mueller Hinton Agar with supplements and 1% hemogl

Device Class :

Duns Number: 039981550

Premarket Exempt : No

Product Code : JTZ

Prescription Use : Yes

Device Count : 10

NA - 00816576020041 Catalog Number : E30

Device Description : MODIFIED THAYER MARTINFor the selective isolation of Neisseria gonorrhoeae. Cont

Device Class :

Duns Number: 039981550

Premarket Exempt : No

Product Code : JTY

Prescription Use : Yes

Device Count : 10

NA - 00816576020058 Catalog Number : E31

Device Description : MARTIN LEWIS w/ LINCOMYCIN, PP(Martin Lewis Agar with lincomycin, reduced vancom

Device Class :

Duns Number: 039981550

Premarket Exempt : No

Product Code : JTY

Prescription Use : Yes

Device Count : 10

NA - 00816576020065 Catalog Number : E39

Device Description : MARTIN LEWIS with LINCOMYCIN(Martin Lewis Agar with lincomycin, reduced vancomyc

Device Class :

Duns Number: 039981550

Premarket Exempt : No

Product Code : JTY

Prescription Use : Yes

Device Count : 10

NA - 00816576020089 Catalog Number : E450

Device Description : THAYER MARTIN, MODIFIEDFor the selective isolation of N. gonorrheoeae with suppr

Device Class :

Duns Number: 039981550

Premarket Exempt : No

Product Code : JTY

Prescription Use : Yes

Device Count : 10

HardyCHROM™ - 00816576020096 Catalog Number : GA307

Device Description : HardyCHROM™ MRSA - RSRA selective and differential chromogenic medium for the qu

Device Class :

Duns Number: 039981550

Premarket Exempt : No

Product Code : JSO

Prescription Use : Yes

Device Count : 10

NA - 00816576020102 Catalog Number : G14

Device Description : BHI AGAR with VANCOMYCIN(Brain Heart Infusion Agar with Vancomycin 6mcg/ml). For

Device Class :

Duns Number: 039981550

Premarket Exempt : No

Product Code : JSO

Prescription Use : Yes

Device Count : 10

NA - 00816576020119 Catalog Number : G33

Device Description : HTM AGAR(Haemophilus Test Medium) For disk diffusion sensitivity testing of Haem

Device Class :

Duns Number: 039981550

Premarket Exempt : No

Product Code : JSO

Prescription Use : Yes

Device Count : 10

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