Antisera, All Types, Shigella Spp.
FDA product code GNB · Class II (moderate risk) · 21 CFR 866.3660 · Microbiology
41510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961537 | SAS Shigella Sonnei Form II AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/31/1996SE |
| K961559 | SAS Shigella Dysenteriae Type 9 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961558 | SAS Shigella Flexneri Type 3 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961556 | SAS Shigella Flexneri Type 1 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961554 | SAS Shigella Boydii Type 10 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961553 | SAS Shigella Dysenteriae Type 1 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961551 | SAS Shigella Dysenteriae Type 2 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961549 | SAS Shigella Flexneri Type 2 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961548 | SAS Shigella Boydii Type 15 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961547 | SAS Shigella Boydii Type 14 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961546 | SAS Shigella Boydii Group C1/C1 (8-10) AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961543 | SAS Shigella Boydii Type 9 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961542 | SAS Shigella Flexneri Type 4 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961541 | SAS Shigella Boydii Type 8 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961540 | SAS Shigella Sonnei Group D AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961539 | SAS Shigella Dysenteriae Type 10 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961538 | SAS Shigella Dysenteriae Type 8 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961535 | SAS Shigella Dysenteriae Group A1 (8-10) AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961534 | SAS Shigella Sonnei Form I Antiserum (3/100/1000ML)GNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961533 | SAS Shigella Flexneri Type 6 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961532 | SAS Shigella Flexneri Type 5 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961531 | SAS Shigella Boydii Type 13 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961529 | SAS Shigella Boydii Type 12 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961528 | SAS Shigella Boydii Type 11 Antiserum (3/100/1000ML)GNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K953321 | SAS Shigella Dysenteriae Type 3 AntiserumGNB · Traditional | Sa Scientific, Inc. | 08/04/1995SE |
| K953320 | SAS Shigella Dysenteriae Type 4 AntiserumGNB · Traditional | Sa Scientific, Inc. | 08/04/1995SE |
| K953319 | SAS Shigella Dysenteriae Type 5 AntiserumGNB · Traditional | Sa Scientific, Inc. | 08/04/1995SE |
| K953318 | SAS Shigella Dysenteriae Type 6 AntiserumGNB · Traditional | Sa Scientific, Inc. | 08/04/1995SE |
| K953317 | SAS Shigella Dysenteriae Type 7 AntiserumGNB · Traditional | Sa Scientific, Inc. | 08/04/1995SE |
| K953316 | SAS Shigella Dysenteriae Group a (1-7) AntiserumGNB · Traditional | Sa Scientific, Inc. | 08/04/1995SE |
| K953329 | SAS Shigella Boydii Group C2 AntiserumGNB · Traditional | Sa Scientific, Inc. | 08/02/1995SE |
| K953328 | SAS Shigella Boydii Type 7 AntiserumGNB · Traditional | Sa Scientific, Inc. | 08/02/1995SE |
| K953327 | SAS Shigella Boydii Type 6 AntiserumGNB · Traditional | Sa Scientific, Inc. | 08/02/1995SE |
| K953326 | SAS Shigella Boydii Type 5 AntiserumGNB · Traditional | Sa Scientific, Inc. | 08/02/1995SE |
| K953325 | SAS Shigella Boydii Type 4 AntiserumGNB · Traditional | Sa Scientific, Inc. | 08/02/1995SE |
| K953324 | SAS Shigella Boydii Type 3 AntiserunGNB · Traditional | Sa Scientific, Inc. | 08/02/1995SE |
| K953323 | SAS Shigella Boydii Type 2 AntiserumGNB · Traditional | Sa Scientific, Inc. | 08/02/1995SE |
| K953322 | SAS Shigella Boydii Type 1 AntiserumGNB · Traditional | Sa Scientific, Inc. | 08/02/1995SE |
| K895461 | Wellcolex Colour Shigella Test ZC51GNB · Traditional | Wellcome Diagnostics | 01/11/1990SE |
| K880752 | Phadebact Shigella TestGNB · Traditional | Pharmacia, Inc. | 02/17/1989SE |
| K821337 | Shigella I.D.GNB · Traditional | Analytical Products, Inc. | 05/28/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0290-2018 Class II | Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product…The serum may fail to agglutinate within the specified minimum reaction time. | Remel Inc | 12/08/2017Terminated |
| Z-1528-2008 | Lee Laboratories brand Shigella Antiserum Poly Group B, catalog number 210722, 10 mL…In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false… | Becton Dickinson & Co. | 11/30/2007Terminated |
| Z-1527-2008 | Difco(tm) Shigella Antiserum Poly Group B, Catalog # 228351, in 3 mL vials individually…In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false… | Becton Dickinson & Co. | 11/30/2007Terminated |