Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K212778

Identifiers

510(k) Number: K212778 FDA 510(k)
FDA Product Code: QLX FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 866.3183 FDA 510(k)
Regulation Number: 866.3183 FDA 510(k)
Advisory Committee: Microbiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09… by Abbott Molecular, Inc. — Class II — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K212778	Class II	Active

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Manufacturer

Manufacturer: Abbott Molecular, Inc.

Sources (1)

FDA 510(k) K212778 24 fields · synced Jun 18, 2026