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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name herpes simplex virus nucleic acid amplification assay
510(k) Number K142738
Device Name artus HSV-1/2 QS-RGQ MDx Kit
Applicant
QIAGEN
19300 GERMANTOWN ROAD
germantown,  MD  20874
Applicant Contact lindsey howard
Correspondent
QIAGEN Gaitherburg
1201 Clopper Road
gaithersburg,  MD  20878
Correspondent Contact kimberly mapp
Regulation Number866.3305
Classification Product Code
OQO  
Date Received09/23/2014
Decision Date 12/19/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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