HardyFlask™
DTM (Dermatophyte Test Medium) Agar, plastic HardyFlask™, order by the package of 20 Dermatophyte Test Medium (DTM) is a selective and differential medium recommended for the cultivation…
DTM (Dermatophyte Test Medium) Agar, plastic HardyFlask™, order by the package of 20 Dermatophyte Test Medium (DTM) is a selective and differential medium recommended for the cultivation and isolation of pathogenic dermatophytic fungi.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong Huankai Biology SCI.&Tech.co., Ltd. | Zhaoqing | Guangdong | Manufacturer | 2 |
Record
| Listed by | Hardy Diagnostics, United States |
|---|---|
| FDA product code | JSI |
| Device type | Culture Media, Selective And Differential |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2360 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-06-08 |
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 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| X21 | 20 | In distribution | |
| X15 | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remel | Remel, Inc. | 137 |
| Culture Media, Selective And Differential | Hardy Diagnostics | 102 |
| Edge Biologicals Inc | Edge Biologicals, Inc. | 40 |
| Redipor | Analytichem USA, Inc. | 27 |
| HardyCHROM | Hardy Diagnostics | 11 |
| AnaeroGRO | Hardy Diagnostics | 5 |
| BD BBL™ Sabouraud Dextrose Agar Slants | Becton, Dickinson AND Company | 2 |
| Macconkey Agar (Without Salt) | Oxoid, Ltd. | 2 |
| Pras Laked Brucella Blood Agar w/ Kanamycin & Vancomycin (LKV) | Anaerobe Systems | 2 |
| BD BBL™ Bile Esculin Agar Slants | Becton, Dickinson AND Company | 2 |
| BD BBL™ MacConkey II Agar with Sorbitol | Becton, Dickinson AND Company | 2 |
| BD BBL™ Hektoen Enteric Agar | Becton, Dickinson AND Company | 2 |
Showing 12 of 97. All products under Culture Media, Selective And Differential
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-03-04 | Class II | Employee error | The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack of color development in Shigella organisms in the referenced lot. | 840 (84 pk/10) | 2015-07-13 |
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.