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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
Regulation Description Erythrocytic glucose-6-phosphate dehydrogenase assay.
Product CodeJBF
Regulation Number 864.7360
Device Class 2


Premarket Reviews
ManufacturerDecision
ALERE SCARBOROUGH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1

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

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

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