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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device anti-müllerian hormone test system
Definition An Anti-Müllerian hormone test system is an in vitro diagnostic device intended to measure anti-Müllerian hormone in human serum and plasma. The test is intended to be used as an aid for assessing ovarian reserve in women.
Product CodePQO
Regulation Number 862.1092
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER INC
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 1 1
2022 2 2
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 7 7
Non Reproducible Results 3 3
High Test Results 1 1
Incorrect Measurement 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 5 5
No Clinical Signs, Symptoms or Conditions 4 4

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