HardyDisk™ Z9391

GUDID 00816576021918

Ceftaroline 30μg (CPT30) 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.

HARDY DIAGNOSTICS

Multiple antibacterial susceptibility profile kit IVD

Primary Device ID	00816576021918
NIH Device Record Key	89d25841-7e46-49e2-b0e1-8ca976834e39
Commercial Distribution Status	In Commercial Distribution
Brand Name	HardyDisk™
Version Model Number	Z9391
Catalog Number	Z9391
Company DUNS	039981550
Company Name	HARDY DIAGNOSTICS
Device Count	50
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	800-266-2222
Email	techservice@hardydiagnostics.com
Phone	800-266-2222
Email	techservice@hardydiagnostics.com
Phone	800-266-2222
Email	techservice@hardydiagnostics.com

Operating and Storage Conditions

Storage Environment Temperature

Between -20 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816576021918 [Primary]
GS1	00816576021932 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K103538

FDA Product Code

JTN	Susceptibility Test Discs, Antimicrobial

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-01

On-Brand Devices [HardyDisk™]

00816576028795	HardyDisks™ AST, Plazomicin, Zemdri, for susceptibility testing,5 x 50 disks, by Hardy Diagnos
00816576028788	HardyDisks™ AST, Plazomicin, Zemdri, for susceptibility testing, 1x50 disks, by Hardy Diagnost
00816576023509	HardyDisks™ AST, Meropenem/Vaborbactam, Vabomere, for susceptibility testing, 5 x 50 disks, by
00816576023493	HardyDisks™ AST, Meropenem/Vaborbactam, Vabomere, for susceptibility testing, 1 x 50 disks, by
00816576023479	HardyDisks™ AST, Delafloxacin, Baxdela, for susceptibility testing, 5 x 50 disks, by Hardy Dia
00816576023462	HardyDisks™ AST, Delafloxacin, Baxdela, for susceptibility testing, 1 x 50 disks, by Hardy Dia
00816576022618	HardyDisks™ AST, Eravacycline ERV20, for susceptibility testing,5 x 50 disks, by Hardy Diagnos
00816576022601	HardyDisks™ AST, Eravacycline ERV20, for susceptibility testing,1 x 50 disks, by Hardy Diagnos
00816576022045	Ceftolozane 30μg Tazobactam 10μg (C/T40) HardyDisk™ AST Disks are used for semi-quantitative
00816576022038	Ceftolozane 30μg Tazobactam 10μg (C/T40) HardyDisk™ AST Disks are used for semi-quantitative
00816576022014	Ceftazidime 30μg Avibactam 20μg (CZA50) HardyDisk™ AST Disks are used for semi-quantitative
00816576022007	Ceftazidime 30μg Avibactam 20μg (CZA50) HardyDisk™ AST Disks are used for semi-quantitative
00816576021956	Sulfisoxazole 250μg (G0.25) HardyDisk™ AST Disks are used for semi-quantitative in vitro susc
00816576021949	Sulfisoxazole 250ug (G0.25) HardyDisk™ AST Disks are used for semi-quantitative in vitro susce
00816576021925	Ceftaroline 30μg (CPT30) HardyDisk™ AST Disks are used for semi-quantitative in vitro suscept
00816576021918	Ceftaroline 30μg (CPT30) HardyDisk™ AST Disks are used for semi-quantitative in vitro suscept
00816576021895	Telavancin 30ug (TLV30) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptib
00816576021888	Telavancin 30ug (TLV30) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptib
00816576021864	Doripenem 10ug (DOR10) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibi
00816576021857	Doripenem 10μg (DOR10) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptib
00816576021109	Tigecycline 15μg (TGC15) HardyDisk™ AST Disks are used for semi-quantitative in vitro suscept
00816576021093	Bacitracin 10units (B10) HardyDisk™ AST Disks are used for semi-quantitative in vitro suscepti
00816576021086	Vancomycin 30μg (Va30) HardyDisk™ Antimicrobial Sensitivity Disks are used for semi-quantitat
00816576021079	Vancomycin 30μg (Va30) HardyDisk™ Antimicrobial Sensitivity Disks are used for semi-quantitat
00816576021062	Trimethoprim 5ug (TMP5) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptib
00816576021055	Trimethoprim 5μg (TMP5) HardyDisk™ AST Disks are used for semi-quantitative in vitro suscepti
00816576021048	Tobramycin 10μg (NN10) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptib
00816576021031	Tobramycin 10μg (NN10) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptib
00816576021024	Timentin 85ug (TIM85) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibil
00816576021017	Ticarcillin 75ug (TIC75) HardyDisk™ AST Disks are used for semi-quantitative in vitro suscepti
00816576021000	Ticarcillin 75ug (TIC75) HardyDisk™ AST Disks are used for semi-quantitative in vitro suscepti
00816576020997	Tetracycline 30μg (Te30) HardyDisk™ AST Disks are used for semi-quantitative in vitro suscept
00816576020980	Tetracycline 30μg (Te30) HardyDisk™ AST Disks are used for semi-quantitative in vitro suscept
00816576020973	Sulpha/Trimeth 25μg (SXT25) HardyDisk™ AST Disks are used for semi-quantitative in vitro susc
00816576020966	Sulpha/Trimeth 25μg (SXT25) HardyDisk™ AST Disks are used for semi-quantitative in vitro susc
00816576020959	Streptomycin 10μg (S10) HardyDisk™ AST Disks are used for semi-quantitative in vitro suscepti
00816576020942	Streptomycin 10μg (S10) HardyDisk™ AST Disks are used for semi-quantitative in vitro suscepti
00816576020935	Piperacillin/Tazobactam 110μg (TZP110) HardyDisk™ AST Disks are used for semi-quantitative in
00816576020928	Piperacillin/Tazobactam 110ug (TZP110) HardyDisk™ AST Disks are used for semi-quantitative in
00816576020911	Piperacillin 100μg (PIP100) HardyDisk™ AST Disks are used for semi-quantitative in vitro susc
00816576020904	Piperacillin 100μg (PIP100) HardyDisk™ AST Disks are used for semi-quantitative in vitro susc
00816576020898	Penicillin 10μg (P10) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibi
00816576020881	Penicillin 10μg (P10) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibi
00816576020874	Oxacillin 1μg (OX1) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibili
00816576020867	Oxacillin 1μg (OX1) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibili
00816576020850	Ofloxacin 5ug (OFX5) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibili
00816576020843	Ofloxacin 5μg (OFX5) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibil
00816576020836	Novobiocin 30μg (NB30) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptib
00816576020829	Novobiocin 30ug (NB30) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibi
00816576020812	Norfloxacin 10ug (NOR10) HardyDisk™ AST Disks are used for semi-quantitative in vitro suscepti