Home › Device types › LHL
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
FDA product code LHL · Class 2 · Microbiology
113
Registered devices
0
Adverse events
3
Recalls
18
510(k) clearances
Devices with this code
Mast Assure Antisera — MAST GROUP LIMITEDTrinity Biotech — MARDX DIAGNOSTICS, INC.Legionella pneumophila Serogroup 4 DFA Reagent — PRO-LAB, INCORPORATEDLegionella pneumophila Serogroup 12 DFA Reagent — PRO-LAB, INCORPORATEDL. pneu 1-6/bdglmj DFA Screen — SCIMEDX CORPORATIONTrinity Biotech — MARDX DIAGNOSTICS, INC.Legionella IFA Detectable Control — DIASORIN MOLECULAR LLCTrinity Biotech — MARDX DIAGNOSTICS, INC.NA — HARDY DIAGNOSTICSTrinity Biotech — MARDX DIAGNOSTICS, INC.Prolex L. pneumophila Serogroup 1 Positive Control Latex Reagent — PRO-LAB, INCORPORATEDL.pneu Gr.1(Mono)(HT) 18 Well — SCIMEDX CORPORATIONIFA: BIOCHIP Sequence Legionella pneumophila (IgAGM) — EUROIMMUN Medizinische Labordiagnostika AGL.pneu 1-6(S) 18 Well(HT) — SCIMEDX CORPORATIONKallestad — Bio-RAD Laboratories, Inc.IFA: Legionella Mosaic 4 (IgAGM) — EUROIMMUN Medizinische Labordiagnostika AGProlex Legionella pneumophila Serogroup 8 Latex Reagent — PRO-LAB, INCORPORATEDLegionella pneumophila Serogroup 5 DFA Reagent — PRO-LAB, INCORPORATEDL.pneu 1-6/bdglmj/C Specimen Slide — SCIMEDX CORPORATIONM45a Test Reagent 1 — MICROGEN BIOPRODUCTS LIMITEDLegionella pneumophila Serogroup 3 DFA Reagent — PRO-LAB, INCORPORATEDLegionella pneumophila Serogroup 11 DFA Reagent — PRO-LAB, INCORPORATEDIFA: Legionella Mosaic 4 (IgAGM) — EUROIMMUN Medizinische Labordiagnostika AGProlex Legionella micdadei — PRO-LAB, INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-02-15 | Focus Diagnostics Inc | After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510( |
| 2017-02-15 | Focus Diagnostics Inc | After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510( |
| 2004-12-23 | Diamedix Corporation | The kits belonging to lot #s 30804/30804Z and 91803Z may lose activity, after one or two usages, causing the OD values for the Cut-Off Calibrator and/or Positiv |
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