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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
2022 2 2
2023 1 1
2024 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 4 4
Non Reproducible Results 3 3
Material Integrity Problem 1 1
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 Clinical Signs, Symptoms or Conditions 5 5

Recalls
Manufacturer Recall Class Date Posted
1 GET TESTED INTERNATIONAL AB II Dec-01-2025
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