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 Number | 866.3305
|
Classification Product Code |
|
Date Received | 09/23/2014 |
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
|