HardyDisk™ - Oxacillin 1μg (OX1)HardyDisk™ AST Disks are used - HARDY DIAGNOSTICS

Duns Number:039981550

Device Description: Oxacillin 1μg (OX1)HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibi Oxacillin 1μg (OX1)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.

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More Product Details

Catalog Number

Z8855

Brand Name

HardyDisk™

Version/Model Number

Z8855

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K994134,K994134

Product Code Details

Product Code

JTN

Product Code Name

Susceptibility Test Discs, Antimicrobial

Device Record Status

Public Device Record Key

70a4ad6b-32ef-4a0b-aa99-2428887dd865

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 02, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HARDY DIAGNOSTICS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 630
2 A medical device with a moderate to high risk that requires special controls. 132