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Antisera, All Groups, Salmonella Spp.
FDA product code GRM · Class 2 · Microbiology
597
Registered devices
14
Adverse events
1
Recalls
69
510(k) clearances
Devices with this code
Monovalent Flagella Salmonella Antisera - Factor s — PRO-LAB, INCORPORATEDSalm. Multi Gr. Poly A-E+Vi serum, 3 mL — Ssi Diagnostica A/SSalmonella Phase H:a serum, 3 mL — Ssi Diagnostica A/SSalmonella Group O:11 serum, 3 mL — Ssi Diagnostica A/SNA — REMEL EUROPE LIMITEDSalmonella Phase H:y serum, 3 mL — Ssi Diagnostica A/SSalmonella Gruppe O:59 serum, 3 mL — Ssi Diagnostica A/SPolyvalent Flagella Salmonella Antisera - H Phase 1 & 2 — PRO-LAB, INCORPORATEDSalmonella O Group Pool OMD serum, 1 mL — Ssi Diagnostica A/SSalmonella Gruppe O:39 serum, 3 mL — Ssi Diagnostica A/SSalmonella O Group Pool OMG serum, 3 mL — Ssi Diagnostica A/SMast Assure Antisera — MAST GROUP LIMITEDMonovalent Flagella Salmonella Antisera - Factor a — PRO-LAB, INCORPORATEDNA — HARDY DIAGNOSTICSMast Assure — MAST GROUP LIMITEDNA — HARDY DIAGNOSTICSSalmonella Latex Kit — MICROGEN BIOPRODUCTS LIMITEDMonovalent Flagella Salmonella Antisera - Factor f — PRO-LAB, INCORPORATEDMonovalent Flagella Salmonella Antisera - Factor z23 — PRO-LAB, INCORPORATEDNA — HARDY DIAGNOSTICSMast Assure Antisera — MAST GROUP LIMITEDBD Difco™ Salmonella O Antiserum Factor 25 — BECTON, DICKINSON AND COMPANYBD Difco™ Salmonella O Antiserum Poly G Groups 56, 57, 58, 59, 60, 61 — BECTON, DICKINSON AND COMPANYSalm. Phase Inversion SGG serum, 3 mL — Ssi Diagnostica A/S
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-25 | Remel Europe Ltd. | Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a S |
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