LHLClass II

Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

Microbiology · 21 CFR 866.3300

MDR events0All time

Recalls3All time

Registered firms15Currently listed

510(k) clearances18All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

3 recall events for this product code

Focus Diagnostics Inc
TerminatedMar 27, 2017
Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
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(k) exempt.
Z-1685-2017 · View FDA record ↗
Focus Diagnostics Inc
TerminatedMar 27, 2017
Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
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(k) exempt.
Z-1686-2017 · View FDA record ↗
Diamedix Corporation
TerminatedFeb 15, 2005
The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert.
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 Positive Control to be recovered below their specified ranges.
Z-0541-05 · View FDA record ↗

Registered firms

15 firms currently registered for this product code

510(k) clearances

18 clearances for this product code