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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device groups a, c and g beta-hemolytic streptococcus nucleic acid amplification system
Definition An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.
Product CodePGX
Regulation Number 866.2680
Device Class 2


Premarket Reviews
ManufacturerDecision
QUIDEL CORP.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 3

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 1
Class II 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Focus Diagnostics Inc I Apr-02-2016

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