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HardyDisk™

FDA UDI

Class II (US FDA UDI)

by Hardy Diagnostics

Identity

Trade Name
HardyDisk™ FDA UDI
Generic Name
Multiple antibacterial susceptibility profile kit IVD FDA UDI
Device Name
Sulfisoxazole 250μg (G0.25) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. FDA UDI
Model / Reference
Z9075 FDA UDI
Description
Sulfisoxazole 250μg (G0.25) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. FDA UDI

Identifiers

Catalog Number
Z9075 FDA UDI
Primary DI / UDI-DI
00816576021956 FDA UDI
510(k) Number
K003690 FDA UDI
FDA Product Code
JTN FDA UDI
GMDN Term
Multiple antibacterial susceptibility profile kit IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.1620 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple antibacterial susceptibility profile kit IVD

HardyDisk™ by Hardy Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple antibacterial susceptibility profile kit IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hardy Diagnostics

Sources (1)

  • FDA UDI 4f2d20bc-0f65-42b4-b415-96cd9cd99bf8 37 fields · synced May 30, 2026