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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
Regulation Description Streptococcus spp. nucleic acid-based assay.
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
MESA BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cepheid II Nov-02-2023
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