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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gbs culture media, selective and differential
Definition Culture Medium for GBS Detection
Product CodePQZ
Regulation Number 866.2360
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOMERIEUX, INC.
  SUBSTANTIALLY EQUIVALENT 1
HARDY DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2017 2 2
2018 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Cardinal Health Inc. II May-20-2020
3 Hardy Diagnostics III Nov-10-2020
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