FDA.reportPublic FDA data

HardyDisk™

Primary DI
00816576020409
Brand
HardyDisk™
Company
HARDY DIAGNOSTICS
Model
Z8121
Catalog number
Z8121
Device description
Ceflacor 30μg (CEC30)HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (KirbyBauer)of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have beendescribed for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcusspp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., includingStreptococcus pneumoniae.
Published
2016-09-02
Public version status
Update
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
K994046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994046000HARDYDISK CEFACLOR 30MCGHardy Diagnostics2000-02-01JTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576020409PrimaryGS10
00816576021437Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576020409008165760204098165760204090816576020409
00816576021437008165760214378165760214370816576021437

GMDN Terms#

Term, Definition table
TermDefinition
Cefaclor susceptibility testing disc IVDA susceptibility testing disc impregnated with a defined amount of the antimicrobial cefaclor, intended to be used to determine the antimicrobial susceptibility of a specific microorganism isolated from a clinical specimen by culture, using a disc diffusion method.

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
50
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

Other Devices Sharing Product Codes#

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