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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device autoantibodies, anti-ribonucleic acid polymerase (rnap) iii antibody
Definition The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase iii antibodies in human serum. The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the clinical and other laboratory findings. For in-vitro diagnostic use.
Product CodeNYO
Regulation Number 866.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
IMMCO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 2 2

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

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