Product code GNB
- Device name
- Antisera, All Types, Shigella Spp.
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3660
- 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 |
|---|---|---|---|
| K961537 | SAS SHIGELLA SONNEI FORM II ANTISERUM | Sa Scientific, Inc. | 1996-05-31 |
| K961546 | SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961533 | SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961534 | SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) | Sa Scientific, Inc. | 1996-05-20 |
| K961535 | SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961538 | SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961539 | SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961540 | SAS SHIGELLA SONNEI GROUP D ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961541 | SAS SHIGELLA BOYDII TYPE 8 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961542 | SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961543 | SAS SHIGELLA BOYDII TYPE 9 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961532 | SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961547 | SAS SHIGELLA BOYDII TYPE 14 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961548 | SAS SHIGELLA BOYDII TYPE 15 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961549 | SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961551 | SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961553 | SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961554 | SAS SHIGELLA BOYDII TYPE 10 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961556 | SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961558 | SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961559 | SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961531 | SAS SHIGELLA BOYDII TYPE 13 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961529 | SAS SHIGELLA BOYDII TYPE 12 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961528 | SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML) | Sa Scientific, Inc. | 1996-05-20 |
| K953316 | SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ANTISERUM | Sa Scientific, Inc. | 1995-08-04 |
| K953317 | SAS SHIGELLA DYSENTERIAE TYPE 7 ANTISERUM | Sa Scientific, Inc. | 1995-08-04 |
| K953318 | SAS SHIGELLA DYSENTERIAE TYPE 6 ANTISERUM | Sa Scientific, Inc. | 1995-08-04 |
| K953319 | SAS SHIGELLA DYSENTERIAE TYPE 5 ANTISERUM | Sa Scientific, Inc. | 1995-08-04 |
| K953320 | SAS SHIGELLA DYSENTERIAE TYPE 4 ANTISERUM | Sa Scientific, Inc. | 1995-08-04 |
| K953321 | SAS SHIGELLA DYSENTERIAE TYPE 3 ANTISERUM | Sa Scientific, Inc. | 1995-08-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05056080500928 | Shigella boydii polyvalent 1 (1-6) Agglutinating Serum | REMEL EUROPE LIMITED | 2026-05-05 |
| 15060392377786 | Mast Assure Antisera | MAST GROUP LIMITED | 2024-01-09 |
| 15060392377991 | Mast Assure Antisera | MAST GROUP LIMITED | 2024-01-09 |
| 15060392377984 | Mast Assure Antisera | MAST GROUP LIMITED | 2024-01-09 |
| 15060392377960 | Mast Assure Antisera | MAST GROUP LIMITED | 2024-01-09 |
| 15060392377953 | Mast Assure Antisera | MAST GROUP LIMITED | 2024-01-09 |
| 15060392377946 | Mast Assure Antisera | MAST GROUP LIMITED | 2024-01-09 |
| 15060392377892 | Mast Assure Antisera | MAST GROUP LIMITED | 2024-01-09 |
| 15060392377762 | Mast Assure Antisera | MAST GROUP LIMITED | 2024-01-09 |
| 15060392377793 | Mast Assure Antisera | MAST GROUP LIMITED | 2024-01-09 |
| 05060472462749 | Polyvalent Shigella Slide Antisera - boydii 1-15 | PRO-LAB, INCORPORATED | 2022-12-20 |
| 05060472462732 | Polyvalent Shigella Slide Antisera - dysenteriae 1-10 | PRO-LAB, INCORPORATED | 2022-12-20 |
| 05060472462725 | Polyvalent Shigella Slide Antisera - flexneri 1-6 X & Y | PRO-LAB, INCORPORATED | 2022-12-20 |
| 05060472462718 | Polyvalent Shigella Slide Antisera - sonnei Phase 1 & 2 | PRO-LAB, INCORPORATED | 2022-12-20 |
| 15060392377922 | Mast Assre | MAST GROUP LIMITED | 2022-01-05 |
| 15060392377854 | Mast Assure | MAST GROUP LIMITED | 2022-01-05 |
| 15060392377878 | Mast Assure | MAST GROUP LIMITED | 2022-01-05 |
| 15060392377885 | Mastr Assure | MAST GROUP LIMITED | 2022-01-05 |
| 15060392377939 | Mast Assure | MAST GROUP LIMITED | 2022-01-05 |
| 15060392377908 | Mast Assure | MAST GROUP LIMITED | 2022-01-05 |
| 15060392376390 | Mast Assure Antisera | MAST GROUP LIMITED | 2021-10-15 |
| 15060392377861 | Mast Assure Antisera | MAST GROUP LIMITED | 2021-10-15 |
| 15060392377717 | Mast Assure Antisera | MAST GROUP LIMITED | 2021-08-05 |
| 15060392377700 | Mast Assure Antisera | MAST GROUP LIMITED | 2021-06-16 |
| 15060392377724 | Mast Assure Antisera | MAST GROUP LIMITED | 2021-06-16 |
| 15060392377731 | Mast Assure Antisera | MAST GROUP LIMITED | 2021-06-16 |
| 15060392377748 | Mast Assure Antisera | MAST GROUP LIMITED | 2021-06-16 |
| 15060392377755 | Mast Assure Antisera | MAST GROUP LIMITED | 2021-06-16 |
| 15060392376345 | Mast Assure Antisera | MAST GROUP LIMITED | 2021-06-07 |
| 15060392377694 | Mast Assure Antisera | MAST GROUP LIMITED | 2021-06-07 |