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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device glucose-6-phosphate dehydrogenase (erythrocytic), screening
Product CodeJBF
Regulation Number 864.7360
Device Class 2


Premarket Reviews
ManufacturerDecision
ALERE SCARBOROUGH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAEBIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 1 1
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 4 4
Non Reproducible Results 2 2
False Positive Result 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 4 4
No Known Impact Or Consequence To Patient 2 2
No Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Pointe Scientific, Inc. II Aug-31-2015
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