HardyDisk™ Z8325

GUDID 00816576020539

Cefuroxime 30μg (CXM30) 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

Cefuroxime sodium susceptibility testing disc IVD Cefuroxime sodium susceptibility testing disc IVD Cefuroxime sodium susceptibility testing disc IVD
Primary Device ID00816576020539
NIH Device Record Keyc27b408b-c3da-4328-8dac-ba0ded5e19e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameHardyDisk™
Version Model NumberZ8325
Catalog NumberZ8325
Company DUNS039981550
Company NameHARDY DIAGNOSTICS
Device Count250
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816576020539 [Primary]
GS100816576021505 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JTNSusceptibility Test Discs, Antimicrobial

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-02

On-Brand Devices [HardyDisk™]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.