QTM

Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.

Product code: QTM
Device name: Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.
Device class: Class 2
21 CFR: 21 CFR 866.3920
Medical specialty: Microbiology
Marketing pathway: 510(K)

FDA classification definition

Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use for blood donor screening.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QTM

Classification and pathway per current FDA publications. Data from openFDA (CC0).