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510(k) K170284

Great Basin Bordetella Direct Test by Great Basin Scientific, Inc. — Product Code OZZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2017
Date Received
January 30, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bordetella Pertussis Dna Assay System
Device Class
Class II
Regulation Number
866.3980
Review Panel
MI
Submission Type

A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.

Other clearances by Great Basin Scientific, Inc.

  • K163571 — Great Basin Stool Bacterial Pathogens Panel (July 12, 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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