Antisera, All Groups, Salmonella Spp.
FDA product code GRM · Class II (moderate risk) · 21 CFR 866.3550 · Microbiology
69510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961967 | SAS Salmonella O Poly B AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961966 | SAS Salmonella O Group X Factor 47 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961964 | SAS Salmonella O Group H Factors 14,24,25 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961963 | SAS Salmonella O Group W Factor 45 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961962 | SAS Salmonella O Group V Factor 44 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961961 | SAS Salmonella H F,G,T AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961960 | SAS Salmonella H Z4, Z24 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961958 | SAS Salmonella H Z4 Complex AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961957 | SAS Salmonella H Z4, Z32 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961956 | SAS Salmonella H G,M,Q AntisermuGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961955 | SAS Salmonella H Z42 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961954 | SAS Salmonella H Z35 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961953 | SAS Salmonela H Z24 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961952 | SAS Salmonella O Factor /O Group a Factor 2 AntiserumsGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961951 | SAS Salmonella O Factor 6 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961950 | SAS Salmonella O Factor 15 Antiserum &/Or O Group E2 Factor 15 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961949 | SAS Salmonella O Factor 14 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961948 | SAS Salmonella O Factor 20 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K960461 | SAS Salmonella O Group R Factor 40 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/12/1996SE |
| K960160 | SAS Salmonella 0 Group M Factor 28 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/12/1996SE |
| K960147 | SAS Salmonella 0 Group E Factors 1,3,10,15,19,34 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/12/1996SE |
| K960130 | SAS Salmonella O Group Z Factor 50 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/12/1996SE |
| K960129 | SAS Salmonella O Group Y Factor 48 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/12/1996SE |
| K960465 | SAS Salmonella O Group P Factor 38 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960463 | SAS Salmonella O Group U Factor 43 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960462 | SAS Salmonella O Group Q Factor 39 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960460 | SAS Salmonella O Factor 46 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960459 | SAS Salmonella O Group S Factor 41 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960458 | SAS Salmonella O Group T Factor 42 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960163 | SAS Salmonella 0 Factor Factor 5 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960162 | SAS Salmonella 0 Group 0 Factor 35 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960161 | SAS Salmonella 0 Group N Factor 30 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960153 | SAS Salomnella 0 Group L Factor 21 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960152 | SAS Salmonella 0 Factor 12 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960150 | SAS Salmonella 0 Group J Factor 17 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960149 | SAS Salmonella 0 Group F Factor 11 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960145 | SAS Salmonella 0 Factor 27 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960142 | SAS Salmonella 0 Factor 23 Antiserum And/Or SAS Slamonella 0 Group G2 Factor 23 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960140 | SAS Salmonella 0 Factor Antiserum And/Or SAS Salmonella 0 Group C1 Factor 7 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960138 | SAS Salmonella 0 Factor 8 Antiserum And/Or SAS Salmonella 0 Group C2 Factor 9 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960137 | SAS Salmonella H Z10 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960136 | SAS Salmonella H P AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960135 | SAS Salmonella H M AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960134 | SAS Salmonella 0 Factor 9 Antiserum And/Or SAS Salmonella 0 Group D Factor 9 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960132 | SAS Salmonella H U AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960127 | SAS Salmonella O Factor 22 Antiserum &/Or SAS Salmonella O Group G1 Factor 22 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960126 | SAS Salmonella O Factor 19 Antiserum &/Or SAS Salmonella O Group E4 Factor 19 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960125 | SAS Salmonella O Factor 4 Antiserum &/Or SAS Salmonella O Group B Factor 4,5 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960124 | SAS Salmonella 0 Factor 10 Antiserum And/Or SAS Salmonella 0 Group E1 Factor 10 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960123 | SAS Salmonella O Factor 18 Antiserum &/Or SAS Salmonella O Group K Factor 18 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/06/1996SE |
| K960610 | SAS Salmonella H Z15 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/04/1996SE |
| K960609 | SAS Salmonella H Z32 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/04/1996SE |
| K960603 | SAS Salmonella H Z23 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/04/1996SE |
| K960335 | SAS Salmonella H Poly A-Z AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/04/1996SE |
| K960333 | SAS Salmonella H G,P,U AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/04/1996SE |
| K960331 | SAS Salmonella H Z28 AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/04/1996SE |
| K960133 | SAS Salmonella H F AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/04/1996SE |
| K960131 | SAS Salmonella H G AntiserumGRM · Traditional | Sa Scientific, Inc. | 03/04/1996SE |
| K955222 | SAS Spicer-Edwards 1 ComplexGRM · Traditional | Sa Scientific, Inc. | 02/13/1996SE |
| K952288 | SAS Salmonella H C AntiserumGRM · Traditional | Sa Scientific, Inc. | 07/25/1995SE |
| K952134 | SAS Salmonella H Poly Positive AntiserumGRM · Traditional | Sa Scientific, Inc. | 07/21/1995SE |
| K952133 | SAS Salmonella O Poly Positive AntiserumGRM · Traditional | Sa Scientific, Inc. | 07/21/1995SE |
| K951069 | SAS Salmonella H B AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/09/1995SE |
| K943400 | SAS Salmonella H D AntiserumGRM · Traditional | Sa Scientific, Inc. | 11/02/1994SE |
| K912791 | Salmonella O Grouping Antisera SetGRM · Traditional | S.M.I. Medical, Inc. | 10/05/1992SE |
| K910438 | Dipstick SalmonellaGRM · Traditional | Ampcor, Inc. | 09/13/1991SE |
| K890146 | Wellcolex Colour Salmonella Test ZL 50GRM · Traditional | Wellcome Diagnostics | 02/16/1989SE |
| K870813 | Bactigen Salmonella-Shigella TestGRM · Traditional | Armkel, LLC | 04/22/1987SE |
| K821338 | Salmonella I.D.GRM · Traditional | Analytical Products, Inc. | 05/28/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1923-2026 Class II | Oxoid Agglutinating Sera, Salmonella 9-0 R30957301Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds.… | Remel Europe Ltd. | 03/25/2026Open, Classified |