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
Trinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.Legionella IFA Substrate Slides — DIASORIN MOLECULAR LLCProlex Legionella pneumophila Serogroup 14 Latex Reagent — PRO-LAB, INCORPORATEDProlex Legionella micdadei — PRO-LAB, INCORPORATEDTrinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.IFA: Legionella pneumophila Screening (Mix 1) (IgAGM) — EUROIMMUN Medizinische Labordiagnostika AGTrinity Biotech — MARDX DIAGNOSTICS, INC.NA — HARDY DIAGNOSTICSLegionella pneumophila Serogroup 13 DFA Reagent — PRO-LAB, INCORPORATEDLegionella pneumophila Serogroup 5 DFA Reagent — PRO-LAB, INCORPORATEDTrinity Biotech — MARDX DIAGNOSTICS, INC.Legionella pneumophila Serogroup 7 DFA Reagent — PRO-LAB, INCORPORATEDLegionella pneumophila Screening (Mix 1/2/3/4) IFA (IgAGM) — EUROIMMUN Medizinische Labordiagnostika AGTrinity Biotech — MARDX DIAGNOSTICS, INC.IFA: Legionella pneumophila Screening (Mix 1 / Mix 2) (IgAGM) — EUROIMMUN Medizinische Labordiagnostika AGL.pneu 1-6(S) 6 Well Slide — SCIMEDX CORPORATIONProlex Legionella pneumophila Serogroup 6 Latex Reagent — PRO-LAB, INCORPORATEDTrinity Biotech — MARDX DIAGNOSTICS, INC.IFA: Legionella Mosaic 4 (IgAGM) — EUROIMMUN Medizinische Labordiagnostika AGTrinity Biotech — MARDX DIAGNOSTICS, INC.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.