Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.
Medical specialty
Microbiology
Device class
2
Regulation number
866.3920
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use for blood donor screening.