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510(k) K133936

ARTUS C. DIFFICILE QS-RGQ MDX KIT by QIAGEN GmbH — Product Code OZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2014
Date Received
December 23, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C. Difficile Toxin Gene Amplification Assay
Device Class
Class II
Regulation Number
866.3130
Review Panel
MI
Submission Type

Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.

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  • K171441 — ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Ki (July 21, 2017)
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  • K163085 — Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack (February 14, 2017)
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