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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nucleic acid amplification assay system, group b streptococcus, direct specimen test
Definition A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status.
Product CodeNJR
Regulation Number 866.3740
Device Class 1


Premarket Reviews
ManufacturerDecision
CEPHEID
  SUBSTANTIALLY EQUIVALENT 1
DIAGENODE
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN MOLECULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
NEUMODX MOLECULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 2 2
2022 3 3
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 5 5
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hologic, Inc II Apr-06-2022
2 Luminex Corporation II Aug-15-2019
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