DIASORIN LIAISON CMV IGM/IGG

Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

DIASORIN S.P.A.

The following data is part of a premarket notification filed by Diasorin S.p.a. with the FDA for Diasorin Liaison Cmv Igm/igg.

Pre-market Notification Details

Device IDK040290
510k NumberK040290
Device Name:DIASORIN LIAISON CMV IGM/IGG
ClassificationEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Applicant DIASORIN S.P.A. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater,  MN  55082 -0285
ContactDavid M Ikeda
CorrespondentDavid M Ikeda
DIASORIN S.P.A. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater,  MN  55082 -0285
Product CodeLFZ  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-06
Decision Date2005-06-01
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.