QTM — Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening. Class II
FDA product code QTM covers "Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.", a Class II medical device regulated under 21 CFR 866.3920. Submissions are reviewed by the Microbiology panel.
Classification Details
- Product Code
- QTM
- Device Class
- Class II
- Regulation Number
- 866.3920
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use for blood donor screening.