HardyFlask™
BHI (Brain Heart Infusion) Agar with Chloramphenicol and Cycloheximide, plastic HardyFlask™, order by the package of 20 Brain Heart Infusion (BHI) Agar is a general purpose nutrient medium…
BHI (Brain Heart Infusion) Agar with Chloramphenicol and Cycloheximide, plastic HardyFlask™, order by the package of 20 Brain Heart Infusion (BHI) Agar is a general purpose nutrient medium recommended for the cultivation and isolation of a variety of microorganisms, including bacteria, yeasts, and molds. The addition of defibrinated sheep blood and antimicrobics produces a selective medium used for the isolation of pathogenic fungi from specimens heavily contaminated with bacteria and saprophytic fungi.
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
Record
| Listed by | Hardy Diagnostics, United States |
|---|---|
| FDA product code | JSJ |
| Device type | Culture Media, Selective And Non-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 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| X11 | 20 | In distribution | |
| X14 | 20 | In distribution | |
| X59 | 20 | In distribution | |
| X19 | 20 | In distribution | |
| X30 | 20 | In distribution | |
| X20 | 20 | In distribution | |
| X23 | 20 | In distribution | |
| X13 | 20 | In distribution | |
| X22 | 20 | In distribution | |
| X12 | 20 | In distribution | |
| X41 | 20 | In distribution | |
| X73 | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remel | Remel, Inc. | 132 |
| Culture Media, Selective And Non-Differential | Hardy Diagnostics | 85 |
| Edge Biologicals Inc | Edge Biologicals, Inc. | 17 |
| Alpha-Tec Systems | Alpha-Tec Systems, Inc. | 11 |
| Redipor | Analytichem USA, Inc. | 9 |
| AnaeroGRO | Hardy Diagnostics | 3 |
| BD BBL™ Campylobacter Agar with 5 Antimicrobics and 10% Sheep Blood | Becton, Dickinson AND Company | 2 |
| BD BBL™ XLD Agar | Becton, Dickinson AND Company | 2 |
| BD BBL™ Selenite-F Broth | Becton, Dickinson AND Company | 2 |
| BD BBL™ Campy CVA Agar | Becton, Dickinson AND Company | 2 |
| BD BBL™ Mycosel™ Agar Slants | Becton, Dickinson AND Company | 2 |
| BD BBL™ Middlebrook and Cohn 7H10 Agar Slants | Becton, Dickinson AND Company | 2 |
Showing 12 of 92. All products under Culture Media, Selective And Non-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 |
|---|---|---|---|---|---|
| 2016-03-21 | Class II | Under Investigation by firm | Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product deterioration. | 3,530 (353 pk/10) | 2016-10-25 |
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.