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Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)

FDA product code LJC · Class 1 · Microbiology

4
Registered devices
25
Adverse events
7
Recalls
67
510(k) clearances

Devices with this code

Trinity Biotech — CLARK LABORATORIES, INC.QuickVue — QUIDEL CORPORATIONSeroELISA Chlamydia IgA — SAVYON DIAGNOSTICS LTDSeroELISA Chlamydia IgG — SAVYON DIAGNOSTICS LTD

Recent recalls

DateFirmReason
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2011-07-08bioMerieux, Inc.Complaints were received of high rates of false positive results, leading to unnecessary antibiotic therapy being prescribed to patients.
2008-08-27Calbiotech IncThe recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard rel
2008-08-27Calbiotech IncThe recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard rel
2003-08-06bioMerieuxProduct's decrease in sensitivity may result in false negative results
2003-02-07Thermo Biostar, IncorporatedChlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.
2003-02-07Thermo Biostar, IncorporatedChlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.

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