HYBRID CAPTURE SYSTEM CMV DNA ASSAY

Antigen, Iha, Cytomegalovirus

DIGENE CORP.

The following data is part of a premarket notification filed by Digene Corp. with the FDA for Hybrid Capture System Cmv Dna Assay.

Pre-market Notification Details

Device IDK974901
510k NumberK974901
Device Name:HYBRID CAPTURE SYSTEM CMV DNA ASSAY
ClassificationAntigen, Iha, Cytomegalovirus
Applicant DIGENE CORP. 9000 VIRGINIA MANOR RD., Beltsville,  MD  20705
ContactConstance A Finch
CorrespondentConstance A Finch
DIGENE CORP. 9000 VIRGINIA MANOR RD., Beltsville,  MD  20705
Product CodeLJO  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-31
Decision Date1998-09-29
Summary:summary

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