Product code GRL
- Device name
- Antigens, All Groups, Salmonella Spp.
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3550
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05713106821527 | S. Braenderup reference strain | Ssi Diagnostica A/S | 2016-09-15 |
| 05713106821510 | S. Agona reference strain | Ssi Diagnostica A/S | 2016-09-15 |
| 05713106821671 | S. Virchow reference strain | Ssi Diagnostica A/S | 2016-09-15 |
| 05713106821664 | S. Typhimurium reference strain | Ssi Diagnostica A/S | 2016-09-15 |
| 05713106821657 | S. Stanley reference strain | Ssi Diagnostica A/S | 2016-09-15 |
| 05713106821640 | S. Senftenberg reference strain | Ssi Diagnostica A/S | 2016-09-15 |
| 05713106821633 | S. Saintpaul reference strain | Ssi Diagnostica A/S | 2016-09-15 |
| 05713106821626 | S. Paratyphi A reference strain | Ssi Diagnostica A/S | 2016-09-15 |
| 05713106821619 | S. Newport reference strain | Ssi Diagnostica A/S | 2016-09-15 |
| 05713106821602 | S. Montevideo reference strain | Ssi Diagnostica A/S | 2016-09-15 |
| 05713106821589 | S. Infantis reference strain | Ssi Diagnostica A/S | 2016-09-15 |
| 05713106821572 | S. Heidelberg reference strain | Ssi Diagnostica A/S | 2016-09-15 |
| 05713106821558 | S. Hadar reference strain | Ssi Diagnostica A/S | 2016-09-15 |
| 05713106821541 | S. Enteritidis reference strain | Ssi Diagnostica A/S | 2016-09-15 |
| 05713106821534 | S. Derby reference strain | Ssi Diagnostica A/S | 2016-09-15 |
| 00382902117575 | BD Difco™ QC Antigen Salmonella O Group I | BECTON, DICKINSON AND COMPANY | 2016-07-07 |
| 00382902117544 | BD Difco™ QC Antigen Salmonella O Group G1 | BECTON, DICKINSON AND COMPANY | 2016-07-07 |
| 00382902117537 | BD Difco™ QC Antigen Salmonella O Group F | BECTON, DICKINSON AND COMPANY | 2016-07-07 |
| 00382902117513 | BD Difco™ QC Antigen Salmonella O Group E2 | BECTON, DICKINSON AND COMPANY | 2016-07-07 |
| 00382902117506 | BD Difco™ QC Antigen Salmonella O Group E1 | BECTON, DICKINSON AND COMPANY | 2016-07-07 |
| 00382902213116 | BD Difco™ QC Antigen Salmonella O Group B | BECTON, DICKINSON AND COMPANY | 2016-04-28 |
| 00382902213017 | BD Difco™ QC Antigen Salmonella O Group A | BECTON, DICKINSON AND COMPANY | 2016-04-28 |
| 00695684015039 | SALMONELLA O GROUP D ANTIGEN | GERMAINE LABORATORIES, INC | 2016-04-27 |
| 00695684015022 | SALMONELLA O GROUP C ANTIGEN | GERMAINE LABORATORIES, INC | 2016-04-21 |
| 00695684015015 | SALMONELLA O GROUP B ANTIGEN | GERMAINE LABORATORIES, INC | 2016-04-21 |
| 00695684015008 | SALMONELLA O GROUP A ANTIGEN | GERMAINE LABORATORIES, INC | 2016-04-21 |
| 00695684014032 | SALMONELLA H d ANTIGEN | GERMAINE LABORATORIES, INC | 2016-04-21 |
| 00695684014025 | SALMONELLA H c ANTIGEN | GERMAINE LABORATORIES, INC | 2016-04-21 |
| 00695684014018 | SALMONELLA H b ANTIGEN | GERMAINE LABORATORIES, INC | 2016-04-21 |
| 00695684014001 | SALMONELLA H a ANTIGEN | GERMAINE LABORATORIES, INC | 2016-04-21 |