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510(k) K163571

Great Basin Stool Bacterial Pathogens Panel by Great Basin Scientific, Inc. — Product Code PCI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2017
Date Received
December 19, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
Device Class
Class II
Regulation Number
866.3990
Review Panel
MI
Submission Type

A gastrointestinal bacterial panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal bacterial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal bacterial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.

Other clearances by Great Basin Scientific, Inc.

  • K170284 — Great Basin Bordetella Direct Test (March 31, 2017)
  • K152470 — Great Basin Staph ID/R Blood Culture Panel (March 25, 2016)
  • K152955 — Great Basin Shiga Toxin Direct Test (March 22, 2016)
  • DEN120013 — PORTRAIT ANALYZER (April 30, 2012)

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