Redipor
Colorex Orientation Agar TSA with 5% Sheep Blood
1manufacturer
27catalogue numbers in this listing
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 | Analytichem USA, Inc., United States |
|---|---|
| FDA product code | JSI |
| Device type | Culture Media, Selective And Differential |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2360 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-21 |
| Record revised | 2025-11-27 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2025-11-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Withdrawn | |
| 1 | Withdrawn |
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 |
| 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 |
| BD BBL™ Levine EMB Agar | Becton, Dickinson AND Company | 2 |
Showing 12 of 97. All products under Culture Media, Selective And Differential
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. 2 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-12-21 | Class II | No Marketing Application | Product marketed without a 510 (k) | 11720 | 2016-04-07 |
| 2015-12-21 | Class II | No Marketing Application | Product marketed without a 510 (k) | 9300 | 2016-04-07 |
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.