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510(k) K132843

VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) by Nanosphere, Inc. — Product Code PEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2014
Date Received
September 10, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gram-Negative Bacteria And Associated Resistance Markers
Device Class
Class II
Regulation Number
866.3365
Review Panel
MI
Submission Type

A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.

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  • K120466 — VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) (November 6, 2012)
  • K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST (September 19, 2012)
  • DEN120014 — VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) (June 26, 2012)
  • K112424 — VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) (December 16, 2011)
  • K103209 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) (January 10, 2011)
  • K093337 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (November 17, 2009)
  • K092957 — VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST (October 21, 2009)

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