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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme linked immunoabsorbent assay, cytomegalovirus
Regulation Description Cytomegalovirus serological reagents.
Product CodeLFZ
Regulation Number 866.3175
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 5
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
DIASORIN
  SUBSTANTIALLY EQUIVALENT 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
False negative result 17
Low test results 7
Incorrect or inadequate result 6
Incorrect or inadequate test results 3
High test results 2
Defective item 2
No Known Device Problem 2
False positive result 2
Tubing, incorrect placement of 1
Total Device Problems 42

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