Home › Device types › LRM
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
FDA product code LRM · Class 2 · Immunology
36
Registered devices
109
Adverse events
3
Recalls
29
510(k) clearances
Devices with this code
Autoimmune EIA — BIO-RAD LABORATORIES, INC.ReQuest — QUEST INTERNATIONAL, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.ANTI-dsDNA — ORGENTEC Diagnostika GmbHBioPlex 2200 — BIO-RAD LABORATORIES, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Autoimmune EIA — BIO-RAD LABORATORIES, INC.QUANTA Lite® HA dsDNA ELISA — INOVA DIAGNOSTICS, INC.Anti-dsDNA Screen ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungBioPlex 2200 — BIO-RAD LABORATORIES, INC.Trinity Biotech — CLARK LABORATORIES, INC.Anti-dsDNA IgG ELISA — DRG International IncAutoimmune EIA — BIO-RAD LABORATORIES, INC.Anti-dsDNA IgM ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungSeraQuest — QUEST INTERNATIONAL, INC.Anti-dsDNA IgA ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungAutoimmune EIA — BIO-RAD LABORATORIES, INC.Anti-dsDNA Screen ELISA — DRG International IncDiamedix — DIAMEDIX CORPORATIONAnti-dsDNA IgM ELISA — DRG International IncAnti-dsDNA IgG ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungTrinity Biotech — CLARK LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-03-02 | Bio-Rad Laboratories Inc | The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits. |
| 2010-03-02 | Bio-Rad Laboratories Inc | The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits. |
| 2008-08-27 | Calbiotech Inc | The 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 |
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