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Antisera, All Types, H. Influenza
FDA product code GRP · Class 2 · Microbiology
29
Registered devices
11
Adverse events
1
Recalls
6
510(k) clearances
Devices with this code
NA — REMEL EUROPE LIMITEDMast Assure Antisera — MAST GROUP LIMITEDPhadebact Haemophilus Test — Mkl Diagnostics ABNA — REMEL EUROPE LIMITEDNA — REMEL EUROPE LIMITEDImmuLex H. influenzae type c antiserum, 1,5 mL — Ssi Diagnostica A/SBD Difco™ Haemophilus Influenzae Antiserum Type b — BECTON, DICKINSON AND COMPANYBD Difco™ Haemophilus Influenzae Antiserum Type e — BECTON, DICKINSON AND COMPANYBD Difco™ Haemophilus Influenzae Antiserum Type a — BECTON, DICKINSON AND COMPANYBD Difco™ Haemophilus influenzae Antiserum Type d — BECTON, DICKINSON AND COMPANYNA — REMEL EUROPE LIMITEDNA — REMEL EUROPE LIMITEDImmuLex H. influenzae type a antiserum, 1,5 mL — Ssi Diagnostica A/SImmuLex H. influenzae polyv. Antiserum, 1,5mL — Ssi Diagnostica A/SBD Directigen™ H. influenzae type b Test Kit — BECTON, DICKINSON AND COMPANYNA — REMEL EUROPE LIMITEDH. influenzae Type b serum, 1 mL — Ssi Diagnostica A/SMast Assure Antisera — MAST GROUP LIMITEDImmuLex H. influenzae type b antiserum, 1,5 mL — Ssi Diagnostica A/SImmuLex H. influenzae type e antiserum, 1,5mL — Ssi Diagnostica A/SBD Difco™ Haemophilus Influenzae Antiserum Type f — BECTON, DICKINSON AND COMPANYMast Assure Antisera — MAST GROUP LIMITEDBD Difco™ Haemophilus influenzae Antiserum Poly Contains Types a, b, c, d, e, f — BECTON, DICKINSON AND COMPANYHaemophilus influenza B IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-08-12 | The Binding Site Group, Ltd. | A deterioration of performance was identified with influenza type B Enzyme Immunoassay Kits with findings of a positive bias with kit controls. Patient sample r |
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