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Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv

FDA product code OMI · Class 2 · Microbiology

5
Registered devices
24
Adverse events
1
Recalls
2
510(k) clearances

Devices with this code

BioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.

Recent recalls

DateFirmReason
2010-12-22BioCheck IncProduct labels indicate that the products are for IVD use and they do not have an approved 510(k).

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