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PREMIER Adenoclone

MERIDIAN BIOSCIENCE, INC. · Model 696007 · UDI-DI 00840733101755

GOD Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Premier Adenoclone is an Enzyme immunoassay (EIA) for the qualitative detection of human adenoviruses directly from stool specimens and confirms the presence of adenovirus in cell culture isolates from respiratory, ophthalmic or enteric specimens.

Recalls

Date	Firm	Reason
2017-05-05	Cell Marque Corporation	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as requir

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.