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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device multi-analyte controls unassayed
Regulation Description Quality control material (assayed and unassayed).
Definition A quality control material (unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (unassayed) for blood gases, electrolytes, enzymes, multianalytes, single (specified) analytes, or urinalysis controls.
Product CodeOHQ
Regulation Number 862.1660
Device Class 1


Premarket Reviews
ManufacturerDecision
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1

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