Chromid® S. Aureus Elite Agar
Selective isolation and direct identification of Staphylococcus aureus
1manufacturer
1catalogue number
11510(k) clearances naming this product code
2recalls on this code
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 | bioMerieux, Inc., 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, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-05-19 |
| Record revised | 2026-01-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Packaging | Pack of 2 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CHROMID® S. aureus Elite agar | 10 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K871094 | 1987-04-03 |
| K871088 | 1987-04-03 |
| K844515 | 1985-01-07 |
| K844535 | 1985-01-05 |
| K830082 | 1983-02-10 |
| K830065 | 1983-02-10 |
| K830072 | 1983-02-09 |
| K830079 | 1983-02-09 |
| K830070 | 1983-02-09 |
| K830064 | 1983-02-09 |
| K830071 | 1983-02-09 |
Recalls
2 of these are 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 |
|---|---|---|---|---|
| 2022-11-09 | Class II | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 10 units |
| 2022-11-09 | Class II | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 1 unit |
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.