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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device human metapneumovirus (hmpv) rna assay system
Definition A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hmpv) rna extracted from human respiratory specimens or viral cultures. Detection of hmpv rna aids in the diagnosis of respiratory hmpv infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infections.
Product CodeOEM
Regulation Number 866.3980
Device Class 2


Premarket Reviews
ManufacturerDecision
GEN-PROBE PRODESSE, INC
  SUBSTANTIALLY EQUIVALENT 1
GEN-PROBE PRODESSE, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 2
QUIDEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 1 1
Erratic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

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