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…
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.
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1), Jilin (1).
Record
Regulatory record for HardyDisk™ | Listed by | Hardy Diagnostics, United States |
| FDA product code | JTO |
| Device type | Discs, Strips And Reagents, Microorganism Differentiation |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2660 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-08-10 |
| Record revised | 2020-12-21 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -20 to 8 °C |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.