HardyDisk™

Primary DI
00816576021086
Brand
HardyDisk™
Company
HARDY DIAGNOSTICS
Model
Z9245
Catalog number
Z9245
Device description
Vancomycin 30μg (Va30)HardyDisk™ Antimicrobial Sensitivity 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 many organisms. Vancomycin is indicated for in vitro activity against gram positive, aerobic microorganisms including Staphylococcus spp., Enterococcus spp., and Streptococcus spp.The vancomycin disk diffusion test alone is unsuitable for detection of decreased susceptibility to vancomycin in Staphylococcus aureus. The CDC has recommended to incorporate the vancomycin screen agar plate (BHI with vancomycin) for susceptibility testing of all S. aureus isolates. Alternatively, the screening may be limited to methicillin resistant S. aureus (MRSA) isolates, since nearly all vancomycin intermediate S. aureus (VISA) are known to be resistant to methicillin and oxacillin.
Published
2016-09-01
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
K000509000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000509000HARDYDISK, VANCOMYCIN 30MCGHardy Diagnostics2000-04-07JTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576021086PrimaryGS10
00816576021819Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576021086008165760210868165760210860816576021086
00816576021819008165760218198165760218190816576021819

GMDN Terms#

Term, Definition table
TermDefinition
Vancomycin susceptibility testing disc IVDA susceptibility testing disc impregnated with a defined amount of the antimicrobial vancomycin, 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
250
Lot or batch
true
Expiration date on label
true

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00819398024600N/AY100Y1002020-06-08
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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
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