Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) DEN180040

Identifiers

510(k) Number: DEN180040 FDA 510(k)
FDA Product Code: QDZ FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 866.3181 FDA 510(k)
Regulation Number: 866.3181 FDA 510(k)
Advisory Committee: Microbiology FDA 510(k)
FDA Decision: DENG FDA 510(k)

Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit by Meridian Bioscience, Inc. — Class II — IVDR, FDA_510K — listed in FDA 510(k), EUDAMED

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	DEN180040	Class II	Active

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Manufacturer

Manufacturer: Meridian Bioscience, Inc.

Sources (2)

FDA 510(k) DEN180040 24 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced May 19, 2026