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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device aquaporin-4 autoantibody
Definition For the determination of autoantibodies to Aquaporin-4 in human serum and plasma. The test may be useful as an aid in the diagnosis of Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD). The test is not to be used alone and is to be used in conjunction with other clinical and radiological (MRI) laboratory findings.
Product CodePNI
Regulation Number 866.5665
Device Class 2


Premarket Reviews
ManufacturerDecision
KRONUS, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

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