Spectra™ Candida Agar
Catalogue number R01833, listed by Remel, Inc., United States, under Culture Media, Selective And Differential. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
9510(k) clearances naming this product code
7recalls 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 | Remel, Inc., United States |
|---|---|
| FDA product code | JSI |
| Device type | Culture Media, Selective And Differential |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2360 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2026-02-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R01833 | 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 |
|---|---|
| K872188 | 1987-06-24 |
| K860707 | 1986-03-11 |
| K843193 | 1984-09-14 |
| K843194 | 1984-09-14 |
| K840338 | 1984-04-17 |
| K840889 | 1984-03-23 |
| K840615 | 1984-03-09 |
| K840190 | 1984-02-17 |
| K800745 | 1980-05-02 |
Recalls
6 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 | Closed |
|---|---|---|---|---|---|
| 2025-07-11 | Class II | Under Investigation by firm | The products may contain surface and subsurface contamination of Listeria monocytogenes. | 371 units | |
| 2025-07-11 | Class II | Under Investigation by firm | The products may contain surface and subsurface contamination of Listeria monocytogenes. | 611 untis | |
| 2025-07-11 | Class II | Under Investigation by firm | The products may contain surface and subsurface contamination of Listeria monocytogenes. | 750 units | |
| 2025-02-13 | Class II | Under Investigation by firm | Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate. | 316 units | |
| 2025-02-13 | Class II | Under Investigation by firm | Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate. | 787 units | |
| 2020-12-10 | Class II | Mixed-up of materials/components | The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended. | 637 units | 2023-07-06 |
| 2007-02-21 | Not classified | Other | False negative results for sorbitol fermenting bacteria such as E. Coli 0157. | 694/10-pack boxes | 2008-03-06 |
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.