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TPLC - Total Product Life Cycle
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Device uric acid test system for at home prescription use
Regulation Description Uric acid test system.
Definition For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only.
Product CodePTC
Regulation Number 862.1775
Device Class 1


Premarket Reviews
ManufacturerDecision
APEX BIOTECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Visgeneer, Inc. II Sep-02-2025
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