Meridian Bioscience, Inc

FDA Filings

This page includes the latest FDA filings for Meridian Bioscience, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
MERIDIAN BIOSCIENCE, INC.
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 6014802006-03-10

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate
Meridian Bioscience, Inc.
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit2018-11-30

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Revogene®
Meridian Bioscience Canada Inc2019-11-11
Revogene® Strep A
Meridian Bioscience Canada Inc2019-10-29
Revogene® Carba C
Meridian Bioscience Canada Inc2019-10-29
MOCK PIE
Meridian Bioscience Canada Inc2019-10-29
Revogene® C. difficile
Meridian Bioscience Canada Inc2019-10-29
Revogene® GBS LB
Meridian Bioscience Canada Inc2019-10-29
ImmunoCard STAT! CAMPY
MERIDIAN BIOSCIENCE, INC.2019-10-28

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