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QTMClass II

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

21 CFR 866.3920 / Microbiology
FDA source (opens on fda.gov)

QTM is the FDA product code for Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening., a class II device type, regulated under 21 CFR 866.3920. FDA's definition for this code reads: "Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use for blood donor screening". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QTM
Device name
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.
FDA definition
Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use for blood donor screening.
Regulation
21 CFR 866.3920
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code