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510(k) DEN120014

VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) by Nanosphere, Inc. — Product Code PAM

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
June 26, 2012
Date Received
June 15, 2012
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

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

A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.

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  • K132843 — VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) (January 8, 2014)
  • K123197 — VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) (December 5, 2012)
  • K120466 — VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) (November 6, 2012)
  • K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST (September 19, 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)

Other clearances for product code PAM

  • K243490 — LIAISON PLEX Gram-Positive Blood Culture Assay (June 6, 2025)
  • K181663 — ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel (December 20, 2018)
  • K163390 — iC-GPC Assay TM for use on the iC-SystemTM (August 8, 2017)
  • K152470 — Great Basin Staph ID/R Blood Culture Panel (March 25, 2016)
  • K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST (September 19, 2012)