Nitrocef Matchbook™

Primary DI
00819398028547
Brand
Nitrocef Matchbook™
Company
HARDY DIAGNOSTICS
Model
Z108
Catalog number
Z108
Device description
Nitrocef Matchbook™, chromogenic nitrocefin test for beta lactamase, on paper strip, 10 tests per packageNew Easy-to-Use MatchBook Format. Hardy Diagnostics now offers a more convenient way of testing ß-lactamase activity in bacteria. The new Nitrocef MatchBook™ is a rapid test that allows you to quickly pick your colonies and perform the test at the same time! Easier and faster than a disk!The rapid Nitrocef test consists of a paper match-stick 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 MatchBookTM 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. Now contains a larger reaction pad.
Published
2020-06-25
Public version status
Update
Distribution status
Not 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
00819398028547PrimaryGS10
00819398027526Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398028547008193980285478193980285470819398028547
00819398027526008193980275268193980275260819398027526

GMDN Terms#

Term, Definition table
TermDefinition
Beta-lactamase detection reagent IVDOne or multiple beta-lactam test reagent(s) [e.g., a cephalosporin (nitrocefin, cefpodoxime) or beta-lactamase inhibitor (clavulanic acid)] in an impregnated disc, strip, or dehydrated in a microplate, intended to be used in microbial testing to detect beta-lactamase enzyme [e.g., extended-spectrum beta-lactamase (ESBL)] production 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
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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