Culture Media, Selective and Non-Differential
BCYE Agar with CCVC, 15x100mm plate, 24ml. Hardy Diagnostics Buffered Charcoal Yeast Extract (BCYE) Agar formulations are recommended for use in the cultivation and primary isolation of…
BCYE Agar with CCVC, 15x100mm plate, 24ml. Hardy Diagnostics Buffered Charcoal Yeast Extract (BCYE) Agar formulations are recommended for use in the cultivation and primary isolation of Legionella spp. in water and other samples suspected of harboring the bacteria. BCYE without Cysteine is for use in conjunction with BCYE Agar containing L-Cysteine for identification of Legionella spp. from clinical and environmental sources.
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 | 2022-11-14 |
| Record revised | 2020-09-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2026-02-05 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| J31 | 10 | In distribution | |
| E11 | 10 | In distribution | |
| G94 | 10 | In distribution | |
| J67 | 10 | In distribution | |
| A63 | 10 | In distribution | |
| C25 | 20 | In distribution | |
| W40 | 10 | In distribution | |
| K69 | 20 | In distribution | |
| A66 | 10 | In distribution | |
| W65 | 10 | In distribution | |
| C38BX | 100 | In distribution | |
| L49 | 20 | In distribution | |
| A137 | 10 | In distribution | |
| W185BX | 50 | In distribution | |
| W74 | 10 | In distribution | |
| C61 | 20 | In distribution | |
| W27 | 10 | In distribution | |
| C27 | 20 | In distribution | |
| A300 | 10 | In distribution | |
| A90 | 10 | In distribution | |
| W94BX | 100 | In distribution | |
| G170 | 10 | In distribution | |
| A60 | 10 | In distribution | |
| W92 | 10 | In distribution | |
| C32 | 20 | In distribution | |
| A300BX | 100 | In distribution | |
| W58 | 5 | In distribution | |
| A65 | 10 | In distribution | |
| W80 | 10 | In distribution | |
| C28 | 20 | In distribution | |
| K39 | 20 | In distribution | |
| A62 | 10 | In distribution | |
| W16 | 10 | In distribution | |
| C38 | 20 | In distribution | |
| A122 | 10 | In distribution | |
| K120 | 20 | In distribution | |
| C23 | 20 | In distribution | |
| Q32 | 20 | In distribution | |
| L47 | 20 | In distribution | |
| A70 | 10 | In distribution | |
| K49 | 20 | In distribution | |
| C21 | 20 | In distribution | |
| A139 | 10 | In distribution | |
| GA50 | 10 | In distribution | |
| L114 | 20 | In distribution | |
| L128 | 20 | In distribution | |
| G08 | 10 | In distribution | |
| J75 | 10 | In distribution | |
| W79 | 10 | In distribution | |
| K128 | 20 | In distribution | |
| L45 | 20 | In distribution | |
| W50 | 10 | In distribution | |
| G04 | 10 | In distribution | |
| W25 | 10 | In distribution | |
| W169 | 10 | In distribution | |
| C29 | 20 | In distribution | |
| J120 | 10 | In distribution | |
| G153 | 10 | In distribution | |
| W76 | 10 | In distribution | |
| R88 | 20 | In distribution | |
| G06 | 10 | In distribution | |
| W73 | 10 | In distribution | |
| G238 | 10 | In distribution | |
| W159 | 10 | In distribution | |
| A72 | 10 | In distribution | |
| J107 | 10 | In distribution | |
| W72 | 10 | In distribution | |
| GA300 | 10 | In distribution | |
| A150 | 10 | In distribution | |
| A12 | 10 | In distribution | |
| GA72 | 10 | In distribution | |
| A40 | 10 | In distribution | |
| G141 | 10 | In distribution | |
| A93 | 10 | In distribution | |
| Z006 | 20 | Withdrawn | |
| J116 | 10 | Withdrawn | |
| W117 | 10 | Withdrawn | |
| G265 | 10 | Withdrawn | |
| W95 | 10 | Withdrawn | |
| G105 | 10 | Withdrawn | |
| J134 | 10 | Withdrawn | |
| R80 | 20 | Withdrawn | |
| L38 | 20 | Withdrawn | |
| J92 | 10 | Withdrawn | |
| A134 | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remel | Remel, Inc. | 132 |
| Edge Biologicals Inc | Edge Biologicals, Inc. | 17 |
| HardyFlask™ | Hardy Diagnostics | 12 |
| 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.