bioMerieux, Inc. — FDA PCCPs

bioMerieux, Inc. holds 3 FDA-authorized PCCPs in this tracker. Here is the full list, newest first.

Other companies

Thermo Fisher Scientific — FDA PCCPs (10)Medtronic Minimed, Inc. — FDA PCCPs (5)Therapixel — FDA PCCPs (4)Hardy Diagnostics — FDA PCCPs (4)Anumana, Inc. — FDA PCCPs (4)Clarius Mobile Health Corp. — FDA PCCPs (4)Thermo Fisher Scientific (Oxoid Ltd.) — FDA PCCPs (3)Mighty Oak Medical — FDA PCCPs (3)Tyto Care , Ltd. — FDA PCCPs (3)Liofilchem s.r.l. — FDA PCCPs (3)Centers for Disease Control and Prevention — FDA PCCPs (3)Ceribell, Inc. — FDA PCCPs (3)

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We read the bioMerieux, Inc. PCCPs in this list, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.

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Source: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.

This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.