Remel
Yersinia Sel (CIN)(deep,add R45050) 20/PK
1manufacturer
137catalogue numbers in this listing
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 | 2022-12-28 |
| Record revised | 2023-08-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-03-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R01406 | In distribution | |
| R02126 | In distribution | |
| R01564 | In distribution | |
| R01292 | In distribution | |
| R01189 | In distribution | |
| R09832 | In distribution | |
| R01998 | In distribution | |
| R01576 | In distribution | |
| R01865 | In distribution | |
| R01561 | In distribution | |
| R01180 | In distribution | |
| R01874 | In distribution | |
| R01045 | In distribution | |
| R01245 | In distribution | |
| R02089 | In distribution | |
| R01860 | In distribution | |
| R02050 | In distribution | |
| R060302 | In distribution | |
| R01044 | In distribution | |
| R02136 | In distribution | |
| R01857 | In distribution | |
| R45050 | In distribution | |
| R01710 | In distribution | |
| R01282 | In distribution | |
| R01318 | In distribution | |
| R02086 | In distribution | |
| R01585 | In distribution | |
| R01227 | In distribution | |
| R01556 | In distribution | |
| R01320 | In distribution | |
| R01231 | In distribution | |
| R01194 | In distribution | |
| R060292 | In distribution | |
| R01938 | In distribution | |
| R01712 | In distribution | |
| R01322 | In distribution | |
| R01877 | In distribution | |
| R01321 | In distribution | |
| R241035 | In distribution | |
| R01806 | In distribution | |
| R01365 | In distribution | |
| R02345 | In distribution | |
| R060294 | In distribution | |
| R01862 | In distribution | |
| R061338 | In distribution | |
| R01856 | In distribution | |
| R01247 | In distribution | |
| R20202 | In distribution | |
| R20201 | In distribution | |
| R01557 | In distribution | |
| R01268 | In distribution | |
| R01056 | In distribution | |
| R02088 | In distribution | |
| R08352 | In distribution | |
| R01982 | In distribution | |
| R01402 | In distribution | |
| R01709 | In distribution | |
| R01858 | In distribution | |
| R20276 | In distribution | |
| R01855 | In distribution | |
| R01310 | In distribution | |
| R02041 | In distribution | |
| R01108 | In distribution | |
| R01246 | In distribution | |
| R01266 | In distribution | |
| R02066 | In distribution | |
| R02040 | In distribution | |
| R02065 | In distribution | |
| R01840 | In distribution | |
| R01583 | In distribution | |
| R02092 | In distribution | |
| R02176 | In distribution | |
| R09999 | In distribution | |
| R01483 | In distribution | |
| R02006 | In distribution | |
| R01480 | In distribution | |
| R01980 | In distribution | |
| R01981 | In distribution | |
| R01558 | In distribution | |
| R02135 | In distribution | |
| R01328 | In distribution | |
| R01580 | In distribution | |
| R01550 | In distribution | |
| R02049 | In distribution | |
| R10067 | In distribution | |
| R02140 | In distribution | |
| R01864 | In distribution | |
| R01653 | In distribution | |
| R09548 | In distribution | |
| R02124 | In distribution | |
| R01481 | In distribution | |
| R09290 | In distribution | |
| R01192 | In distribution | |
| R03343 | In distribution | |
| R01228 | In distribution | |
| R01104 | In distribution | |
| R07102 | In distribution | |
| R01552 | In distribution | |
| R01952 | In distribution | |
| R01400 | In distribution | |
| R20204 | In distribution | |
| R01190 | In distribution | |
| R02162 | Withdrawn | |
| R02010 | Withdrawn | |
| R08152 | Withdrawn | |
| R20385 | Withdrawn | |
| R01525 | Withdrawn | |
| R01323 | Withdrawn | |
| R241045 | Withdrawn | |
| R20433 | Withdrawn | |
| R01195 | Withdrawn | |
| R07326 | Withdrawn | |
| R02061 | Withdrawn | |
| R02322 | Withdrawn | |
| R01875 | Withdrawn | |
| R02053 | Withdrawn | |
| R08172 | Withdrawn | |
| R07089 | Withdrawn | |
| R01841 | Withdrawn | |
| R01562 | Withdrawn | |
| R01615 | Withdrawn | |
| R01511 | Withdrawn | |
| R01057 | Withdrawn | |
| R02095 | Withdrawn | |
| R01455 | Withdrawn | |
| R01348 | Withdrawn | |
| R01316 | Withdrawn | |
| R01714 | Withdrawn | |
| R01861 | Withdrawn | |
| R01842 | Withdrawn | |
| R09897 | Withdrawn | |
| R02096 | Withdrawn | |
| R01867 | Withdrawn | |
| R20205 | Withdrawn | |
| R02068 | Withdrawn | |
| R01262 | Withdrawn | |
| R01286 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| BD BBL™ Levine EMB 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.