FDA.reportPublic FDA data

HardyDisk™

Primary DI
00819398021548
Brand
HardyDisk™
Company
HARDY DIAGNOSTICS
Model
Z9475
Catalog number
Z9475
Device description
Rezafungin 5ug (RZF5), 5 x 50 disks, used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure(Kirby- Bauer) when there is the need to determine the susceptibility of microorganisms to Rezafungin. Product can be used to determine the zone diameter (mm) of Rezafungin against the following microorganisms for which Rezafungin has been shown to be active both clinically and in vitro: Candida albicans, Candida glabrata, Candida parapsilosis, and Candida tropicalist.
Published
2023-09-08
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
K230827000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230827000HardyDisk AST Rezafungin 5µg (RZF5)Hardy Diagnostics2023-06-01JTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398021548PrimaryGS10
00819398021180Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398021548008193980215488193980215480819398021548
00819398021180008193980211808193980211800819398021180

GMDN Terms#

Term, Definition table
TermDefinition
Antifungal susceptibility testing disc IVDA susceptibility testing disc impregnated with a defined amount of a specific antifungal, also know as an antimycotic (i.e., a drug intended for treatment and/or prevention of a fungal infection) intended to be used to determine the susceptibility of a specific fungal organism 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

Contacts#

Phone, Email table
PhoneEmail
800-266-2222technicalservice@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
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00816576027088HardyDisk™HARDY DIAGNOSTICSJTN2025-08-08
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00816576027071HardyDisk™HARDY DIAGNOSTICSJTN2025-07-14
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05032384526123Oxoid Lefamulin (20ug) LMU20 Antimicrobial Susceptibility Test DiscsOXOID LIMITEDJTN2024-10-01
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00819398021180HardyDisk™HARDY DIAGNOSTICSJTN2023-09-08
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00816576028290HardyDisk™HARDY DIAGNOSTICSJTN2020-08-07
00819398028103HardyDisk™HARDY DIAGNOSTICSJTN2020-03-03
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