Product code GRM
- Device name
- Antisera, 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#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K961967 | SAS SALMONELLA O POLY B ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961948 | SAS SALMONELLA O FACTOR 20 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961949 | SAS SALMONELLA O FACTOR 14 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961950 | SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961951 | SAS SALMONELLA O FACTOR 6 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961952 | SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS | Sa Scientific, Inc. | 1996-06-18 |
| K961953 | SAS SALMONELA H Z24 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961954 | SAS SALMONELLA H Z35 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961955 | SAS SALMONELLA H Z42 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961956 | SAS SALMONELLA H G,M,Q ANTISERMU | Sa Scientific, Inc. | 1996-06-18 |
| K961958 | SAS SALMONELLA H Z4 COMPLEX ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961960 | SAS SALMONELLA H Z4, Z24 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961961 | SAS SALMONELLA H F,G,T ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961962 | SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961963 | SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961964 | SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961966 | SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961957 | SAS SALMONELLA H Z4, Z32 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K960147 | SAS SALMONELLA 0 GROUP E FACTORS 1,3,10,15,19,34 ANTISERUM | Sa Scientific, Inc. | 1996-03-12 |
| K960129 | SAS SALMONELLA O GROUP Y FACTOR 48 ANTISERUM | Sa Scientific, Inc. | 1996-03-12 |
| K960130 | SAS SALMONELLA O GROUP Z FACTOR 50 ANTISERUM | Sa Scientific, Inc. | 1996-03-12 |
| K960461 | SAS SALMONELLA O GROUP R FACTOR 40 ANTISERUM | Sa Scientific, Inc. | 1996-03-12 |
| K960160 | SAS SALMONELLA 0 GROUP M FACTOR 28 ANTISERUM | Sa Scientific, Inc. | 1996-03-12 |
| K960460 | SAS SALMONELLA O FACTOR 46 ANTISERUM | Sa Scientific, Inc. | 1996-03-06 |
| K960462 | SAS SALMONELLA O GROUP Q FACTOR 39 ANTISERUM | Sa Scientific, Inc. | 1996-03-06 |
| K960132 | SAS SALMONELLA H U ANTISERUM | Sa Scientific, Inc. | 1996-03-06 |
| K960458 | SAS SALMONELLA O GROUP T FACTOR 42 ANTISERUM | Sa Scientific, Inc. | 1996-03-06 |
| K960163 | SAS SALMONELLA 0 FACTOR FACTOR 5 ANTISERUM | Sa Scientific, Inc. | 1996-03-06 |
| K960465 | SAS SALMONELLA O GROUP P FACTOR 38 ANTISERUM | Sa Scientific, Inc. | 1996-03-06 |
| K960459 | SAS SALMONELLA O GROUP S FACTOR 41 ANTISERUM | Sa Scientific, Inc. | 1996-03-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05060472461971 | Rapid Polyvalent Salmonella Diagnostic Sera RSD 3 | PRO-LAB, INCORPORATED | 2022-12-24 |
| 05060472461964 | Rapid Polyvalent Salmonella Diagnostic Sera RSD 2 | PRO-LAB, INCORPORATED | 2022-12-24 |
| 05060472461957 | Rapid Polyvalent Salmonella Diagnostic Sera RSD 1 | PRO-LAB, INCORPORATED | 2022-12-24 |
| 05060472462039 | Monovalent Somatic Salmonella Antisera - Group D, Factor 9 | PRO-LAB, INCORPORATED | 2022-12-23 |
| 05060472462176 | Monovalent Somatic Salmonella Antisera - Group K, Factor 18 | PRO-LAB, INCORPORATED | 2022-12-23 |
| 05060472462046 | Monovalent Somatic Salmonella Antisera - Group B/D, Factor 12 | PRO-LAB, INCORPORATED | 2022-12-23 |
| 05060472461933 | Polyvalent Flagella Salmonella Antisera - H Phase 1 & 2 | PRO-LAB, INCORPORATED | 2022-12-23 |
| 05060472461940 | Polyvalent Flagella Salmonella Antisera - H Phase 2, Factors 1, 2, 5, 6, 7, z6 | PRO-LAB, INCORPORATED | 2022-12-23 |
| 05060472462060 | Monovalent Somatic Salmonella Antisera - Group E1, Factor 10 | PRO-LAB, INCORPORATED | 2022-12-22 |
| 05060472462169 | Monovalent Somatic Salmonella Antisera - Group J, Factor 17 | PRO-LAB, INCORPORATED | 2022-12-22 |
| 05060472462152 | Monovalent Somatic Salmonella Antisera - Group I, Factor 16 | PRO-LAB, INCORPORATED | 2022-12-22 |
| 05060472462145 | Monovalent Somatic Salmonella Antisera - Group C3, Factor 20 | PRO-LAB, INCORPORATED | 2022-12-22 |
| 05060472462138 | Monovalent Somatic Salmonella Antisera - Group G2, Factor 23 | PRO-LAB, INCORPORATED | 2022-12-22 |
| 05060472462121 | Monovalent Somatic Salmonella Antisera - Group G1, Factor 22 | PRO-LAB, INCORPORATED | 2022-12-22 |
| 05060472462114 | Monovalent Somatic Salmonella Antisera - Group G, Factor 13, 22, 23 | PRO-LAB, INCORPORATED | 2022-12-22 |
| 05060472462107 | Monovalent Somatic Salmonella Antisera - Group F, Factor 11 | PRO-LAB, INCORPORATED | 2022-12-22 |
| 05060472462091 | Monovalent Somatic Salmonella Antisera - Group E3, Factor 34 | PRO-LAB, INCORPORATED | 2022-12-22 |
| 05060472462084 | Monovalent Somatic Salmonella Antisera - Group E4, Factor 19 | PRO-LAB, INCORPORATED | 2022-12-22 |
| 05060472462077 | Monovalent Somatic Salmonella Antisera - Group E2, Factor 15 | PRO-LAB, INCORPORATED | 2022-12-22 |
| 05060472462053 | Monovalent Somatic Salmonella Antisera - Group E, Factor 3, 10, 15, 19, 34 | PRO-LAB, INCORPORATED | 2022-12-22 |
| 05060472462022 | Monovalent Somatic Salmonella Antisera - Group C2, Factor 8 | PRO-LAB, INCORPORATED | 2022-12-22 |
| 05060472462015 | Monovalent Somatic Salmonella Antisera - Group C, Factor 6, 7 | PRO-LAB, INCORPORATED | 2022-12-22 |
| 05060472462008 | Monovalent Somatic Salmonella Antisera - Group B, Factor 5 | PRO-LAB, INCORPORATED | 2022-12-22 |
| 05060472461995 | Monovalent Somatic Salmonella Antisera - Group B, Factor 4 | PRO-LAB, INCORPORATED | 2022-12-22 |
| 05060472461988 | Monovalent Somatic Salmonella Antisera - Group A, Factor 2 | PRO-LAB, INCORPORATED | 2022-12-22 |
| 05060472461919 | Polyvalent Somatic Salmonella Antisera - Polyvalent O A-1+Vi | PRO-LAB, INCORPORATED | 2022-12-22 |
| 05060472461926 | Polyvalent Somatic Salmonella Antisera - Polyvalent O A-S | PRO-LAB, INCORPORATED | 2022-12-22 |
| 15060392375744 | Mast Assure | MAST GROUP LIMITED | 2022-01-05 |
| 05056080501871 | Disposable Cards RT04 | REMEL EUROPE LIMITED | 2021-07-21 |
| 15060392376109 | Mast Assure Antisera | MAST GROUP LIMITED | 2019-09-04 |