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510(k) K171770

cobas Cdiff Nucleic acid test for use on the cobas Liat System by Roche Molecular Systems, Inc. — Product Code OZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2017
Date Received
June 14, 2017
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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  • K172569 — GenePOC CDiff (November 22, 2017)
  • K171441 — ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Ki (July 21, 2017)
  • K170491 — Solana C. difficile Assay (May 11, 2017)
  • K163085 — Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack (February 14, 2017)
  • K142422 — cobas Cdiff Test (May 20, 2015)
  • K133936 — ARTUS C. DIFFICILE QS-RGQ MDX KIT (April 4, 2014)