Home › Device types › LJB
Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
FDA product code LJB · Class 1 · Microbiology
31
Registered devices
28
Adverse events
7
Recalls
11
510(k) clearances
Devices with this code
BioPlex 2200 — BIO-RAD LABORATORIES, INC.NovaLisa Measles Virus IgG — Gold Standard Diagnostics Frankfurt GmbHAvidity: Anti-Measles Virus ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AGReQuest — QUEST INTERNATIONAL, INC.Measles Virus IgG Avidity ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungDiamedix — DIAMEDIX CORPORATIONBioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.ReQuest — QUEST INTERNATIONAL, INC.VIDAS® Measles IgG — BIOMERIEUX SAAnti-Measles Virus ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AGBioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.SeraQuest — QUEST INTERNATIONAL, INC.Trinity Biotech — CLARK LABORATORIES, INC.ASI Measles IgG EIA Test — ARLINGTON SCIENTIFIC, INC.Measles Virus IgG ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungMeasles Virus IgG Avidity ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungMeasles Virus IgG Avidity ELISA — DRG International IncGold Standard Diagnostics Is-Measles IgG ELISA Test Kit — Gold Standard Diagnostics CorporationTrinity Biotech — CLARK LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-01 | Quest International, Inc. | Due to distributing the measles IgG IVD without a premarket approved/cleared. |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote |
| 2008-10-10 | Diamedix Corporation | Possible false-negative test results: The Sample A Diluent Lot # 50768 assigned to Is-Measles IgG Lot #'s 41108 and 41108B has higher conductivity than normal, |
| 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 |
| 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 |
| 2001-03-19 | Zeus Scientific Inc | Mix-up between low positive and negative controls. |
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