Nitrocef Matchbook™

Basic Information

• Brand Name: Nitrocef Matchbook™
• Primary DI: 00819398028547
• Version / Model: Z108
• Catalog Number: Z108
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-06-25
• Public Version: 1
• Public Version Date: 2020-07-03
• Public Version Status: New
• Public Device Record Key: ef6ab53e-7324-4d2d-bad0-eaecbe9dcb74

Device Description

Nitrocef Matchbook™, chromogenic nitrocefin test for beta lactamase, on paper strip, 10 tests per package New 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43557	Beta-lactamase production microbial reagent IVD	A 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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00819398027526	GS1
Primary	00819398028547	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – -10 Degrees Celsius