HardyDisk™

Primary DI
00816576028894
Brand
HardyDisk™
Company
HARDY DIAGNOSTICS
Model
Z7301
Catalog number
Z7301
Device description
New Easy-to-Use Disk Format. Hardy Diagnostics now offers a convenient way of testing ß-lactamase activity in bacteria. The rapid Nitrocef test consists of a disk that is impregnated with the Nitrocefin reagent, which is a chromogenic cephalosporin. This rapid test can yield clinically relevant information earlier than an MIC test. A positive ß-lactamase test can predict resistance to such antibiotics as penicillin, ampicillin, amoxicillin, and other ß-lactamase containing drugs for the following organisms:• Neisseria gonorrhoeae• Haemophilus spp.• Moraxella (Branhamella) catarrhalis• Staphylococcus spp.• Enterococcus spp.• Anaerobes (such as some species of Bacteroides, Porphyromonas, Clostridium, Fusobacterium, Prevotella)The rapid Nitrocef Disk test can be used for all of the above organisms with results in 5 minutes or less, with the exception of some Staphylococcus spp. that may take up to one hour. The ß-lactamase test is preferred to disk diffusion and agar dilution for the detection of plasmid-mediated beta-lactamase resistance in gonococci. These HardyDisks™ are packages loose in a glass vial.
Published
2020-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JTODiscs, Strips And Reagents, Microorganism Differentiation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTODiscs, Strips And Reagents, Microorganism DifferentiationMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576028894PrimaryGS10
00816576028887Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576028894008165760288948165760288940816576028894
00816576028887008165760288878165760288870816576028887

GMDN Terms#

Term, Definition table
TermDefinition
Beta-lactamase production microbial reagent IVDA substance or reactant, sometimes referred to as nitrocefin reagent, intended to be used in microbial testing to detect the enzyme beta-lactamase, produced by a microorganism isolated from a clinical specimen by culture.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-10 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
039981550
Device count
50
Premarket exempt
true
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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