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Antisera, All Groups, N. Meningitidis

FDA product code GTJ · Class 2 · Microbiology

31

Registered devices

1

Adverse events

5

Recalls

16

510(k) clearances

Devices with this code

BD Difco™ Neisseria Meningitidis Antiserum Group Y — BECTON, DICKINSON AND COMPANY NA — REMEL EUROPE LIMITED EDTA Solution — REMEL EUROPE LIMITED NA — REMEL EUROPE LIMITED NA — REMEL EUROPE LIMITED BD Difco™ Neisseria Meningitidis Antiserum Group X — BECTON, DICKINSON AND COMPANY NA — REMEL EUROPE LIMITED BD Difco™ Neisseria Meningitidis Antiserum Group D — BECTON, DICKINSON AND COMPANY NA — REMEL EUROPE LIMITED BD Difco™ Neisseria Meningitidis Antiserum Group W135 — BECTON, DICKINSON AND COMPANY BD Difco™ Neisseria Meningitidis Antiserum Group C — BECTON, DICKINSON AND COMPANY NA — REMEL EUROPE LIMITED BD Directigen™ Neisseria meningitidis Group B and E. coli K1 Test Kit — BECTON, DICKINSON AND COMPANY NA — REMEL EUROPE LIMITED NA — REMEL EUROPE LIMITED BD Directigen™ Meningitis Combo Test Kit — BECTON, DICKINSON AND COMPANY BD Difco™ Neisseria Meningitidis Antiserum Group A — BECTON, DICKINSON AND COMPANY NA — REMEL EUROPE LIMITED BD Directigen™ Specimen Buffer Solution — BECTON, DICKINSON AND COMPANY BD Difco™ Neisseria Meningitidis Antiserum Group B — BECTON, DICKINSON AND COMPANY BD Directigen™ Meningitis Test Negative Control Reagent — BECTON, DICKINSON AND COMPANY BD Directigen™ Meningitis Combo Test Cards — BECTON, DICKINSON AND COMPANY BD Difco™ Neisseria Meningitidis Antiserum Group Z — BECTON, DICKINSON AND COMPANY NA — REMEL EUROPE LIMITED

Recent recalls

Date	Firm	Reason
2026-07-17	Remel Europe Ltd.	Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
2007-09-06	BD Diagnostic Systems / Lee Laboratories	Exhibits cross reactivity with Neisseria meningitides Group W135.
2007-09-06	BD Diagnostic Systems / Lee Laboratories	Exhibits cross reactivity with Neisseria meningitides Group W135.
2007-09-06	BD Diagnostic Systems / Lee Laboratories	Exhibits cross reactivity with Neisseria meningitides Group W135
2007-09-06	BD Diagnostic Systems / Lee Laboratories	Exhibits cross reactivity with Neisseria meningitides Group W135

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