NZB
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Quality Control Material, Genetics, Dna
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5910
- Medical specialty
- Microbiology
- FDA definition
- Dna quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device includes synthetic dna controls and cell-line based controls.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| HEMOSIL F11 & FV DNA CONTROL (K093737) | Instrumentation Laboratory CO | 2010-05-04 |
| INTROL CF PANEL I CONTROL, MODEL: G106 (K083171) | Maine Molecular Quality Controls, Inc. | 2008-12-16 |
| GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL (K063224) | Gentris Corporation | 2006-12-22 |
| INTROL CF PANEL I CONTROL (DEN060007) | Maine Molecular Quality Controls, Inc. | 2006-10-12 |
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