FDA.reportPublic FDA data

HardyDisk™

Primary DI
00819398028165
Brand
HardyDisk™
Company
HARDY DIAGNOSTICS
Model
Z9445
Catalog number
Z9445
Device description
HardyDisk™ AST Imipenem/Relebactam 10/25µg (IMR10/25), 5 x 50 disksHardyDisk™ 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.
Published
2019-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JTNSusceptibility Test Discs, Antimicrobial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTNSusceptibility Test Discs, AntimicrobialMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191931000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191931000HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)Hardy Diagnostics2019-07-31JTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398028165PrimaryGS10
00819398028141Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398028165008193980281658193980281650819398028165
00819398028141008193980281418193980281410819398028141

GMDN Terms#

Term, Definition table
TermDefinition
Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to determine the identification and antimicrobial susceptibility profile of bacteria species isolated from a clinical specimen by culture.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-266-2222techservice@hardydiagnostics.com

Regulatory Flags#

DUNS number
039981550
Device count
250
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816576020058NAE31E312016-09-01
00816576024995N/AG123G1232020-05-18
00816576026968N/AG367G3672024-07-08
00816576027965N/AW95W952020-06-08
00819398028653N/AZ206Z2062020-08-06
00816576027958N/AW95W952020-06-08
00816576024858N/AG105G1052020-05-18
00819398024600N/AY100Y1002020-06-08
00819398024808N/AY110Y1102020-06-09
00819398024907N/AY115Y1152020-06-09
00819398024594N/AY100Y1002020-06-08
00819398023610N/AR76BXR76BX2020-06-05
00819398024242HardyFlask™X26X262020-06-08
00819398025102N/AY130Y1302020-06-09
00819398023603N/AR76BXR76BX2020-06-05
00819398024235HardyFlask™X26X262020-06-08
00819398022118N/AL22L222020-06-03
00819398025560N/AY310Y3102020-06-09
00819398028264N/AMV1MV12020-06-04
00816576027194HardyDisk™Z9495Z94952025-08-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816576027194HardyDisk™HARDY DIAGNOSTICSJTN2025-08-08
00816576027200HardyDisk™HARDY DIAGNOSTICSJTN2025-08-08
00816576027088HardyDisk™HARDY DIAGNOSTICSJTN2025-08-08
00816576027057HardyDisk™HARDY DIAGNOSTICSJTN2025-07-18
00816576027071HardyDisk™HARDY DIAGNOSTICSJTN2025-07-14
00816576026975HardyDisk™HARDY DIAGNOSTICSJTN2025-07-14
05032384516018Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test DiscsOXOID LIMITEDJTN2024-10-28
05032384537723Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test DiOXOID LIMITEDJTN2024-10-28
05032384580231Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test DiscsOXOID LIMITEDJTN2024-10-28
05032384579945Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test DiOXOID LIMITEDJTN2024-10-28
05032384526123Oxoid Lefamulin (20ug) LMU20 Antimicrobial Susceptibility Test DiscsOXOID LIMITEDJTN2024-10-01
05032384088423Ceftazidime (10 ug) CAZ10 Antimicrobial Susceptibility Test DiscsOXOID LIMITEDJTN2024-07-05
05032384574964Ceftazidime (10 ug) CAZ10 Antimicrobial Susceptibility Test DiscsOXOID LIMITEDJTN2024-07-05
00819398020732HardyDisk™HARDY DIAGNOSTICSJTN2023-11-21
00819398020923HardyDisk™HARDY DIAGNOSTICSJTN2023-11-21
00819398020725HardyDisk™HARDY DIAGNOSTICSJTN2023-11-21
00819398021197HardyDisk™HARDY DIAGNOSTICSJTN2023-09-08
00819398021548HardyDisk™HARDY DIAGNOSTICSJTN2023-09-08
00819398021180HardyDisk™HARDY DIAGNOSTICSJTN2023-09-08
00382902322559BD BBL™ Sensi-Disc™ Cefiderocol 30 µgBECTON, DICKINSON AND COMPANYJTN2023-06-16
05032384526116NAOXOID LIMITEDJTN2021-12-07
00816576028283HardyDisk™HARDY DIAGNOSTICSJTN2020-08-07
00816576028306HardyDisk™HARDY DIAGNOSTICSJTN2020-08-07
00816576028290HardyDisk™HARDY DIAGNOSTICSJTN2020-08-07
00819398028103HardyDisk™HARDY DIAGNOSTICSJTN2020-03-03
00819398028110HardyDisk™HARDY DIAGNOSTICSJTN2020-03-03
00819398028097HardyDisk™HARDY DIAGNOSTICSJTN2020-03-03
05032384140480Oxoid™ Moxifloxacin Antimicrobial Susceptibility DisksOXOID LIMITEDJTN2020-01-30