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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
ALERE SCARBOROUGH, INC
  SUBSTANTIALLY EQUIVALENT 1
ALERE SCARBOROUGH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CEPHEID
  SUBSTANTIALLY EQUIVALENT 2
FOCUS DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENEPOC INC.
  SUBSTANTIALLY EQUIVALENT 1
IQUUM INC
  SUBSTANTIALLY EQUIVALENT 1
LUMINEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MESA BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORPORATION
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
No Information 2 2
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cepheid II Nov-02-2023
2 Focus Diagnostics Inc I Apr-02-2016
3 Luminex Corporation II Aug-15-2019
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