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CMV Brite™ Turbo, CMV antigenemia detection kit

IQ Products B.V. · Model VIR-CMV110 BDC · UDI-DI 08717953022301

LIN
1
510(k) clearances
1
Adverse events
0
Recalls
2
Facilities

Description

The CMV Brite™ Turbo Kit is intended for the qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect immunofluorescence in isolated peripheral blood leukocytes obtained from EDTA and heparin anticoagulated human peripheral blood. The detection of CMV pp65 in human leukocytes aids in the diagnosis of acute or reactivated CMV infection.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.