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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

NA — HARDY DIAGNOSTICS Salm. Phase Inversion SG 1 serum, 3 mL — Ssi Diagnostica A/S Salmonella Gruppe O:35 serum, 3 mL — Ssi Diagnostica A/S NA — HARDY DIAGNOSTICS Salm. Multi Gr. Poly A-E+Vi serum, 1 mL — Ssi Diagnostica A/S Polyvalent Somatic Salmonella Antisera - Polyvalent O A-S — PRO-LAB, INCORPORATED Salm. Phase Inversion H:z64 serum, 3 mL — Ssi Diagnostica A/S Salmonella Phase H:z36 serum, 3 ml — Ssi Diagnostica A/S BD Difco™ Salmonella H Antiserum eh — BECTON, DICKINSON AND COMPANY Salmonella Phase H:b serum, 3 mL — Ssi Diagnostica A/S Salmonella O Group Pool OMC serum, 1 mL — Ssi Diagnostica A/S NA — HARDY DIAGNOSTICS NA — HARDY DIAGNOSTICS Mast Assure Antisera — MAST GROUP LIMITED Salmonella Phase H:g,p serum, 3 mL — Ssi Diagnostica A/S Rapid Polyvalent Salmonella Diagnostic Sera RSD 3 — PRO-LAB, INCORPORATED BD Difco™ Salmonella O Antiserum Factor 19 Identifying Factor for Group E4 — BECTON, DICKINSON AND COMPANY Salmonella Factor H:6 serum, 3 mL — Ssi Diagnostica A/S NA — HARDY DIAGNOSTICS NA — REMEL EUROPE LIMITED Salmonella Factor H:s serum, 3 mL — Ssi Diagnostica A/S Monovalent Somatic Salmonella Antisera - Group E, Factor 3, 10, 15, 19, 34 — PRO-LAB, INCORPORATED BD Difco™ Salmonella O Antiserum Factor 14 — BECTON, DICKINSON AND COMPANY NA — REMEL EUROPE LIMITED

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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.