QMA — Blood Collection Device For Cell-Free Nucleic Acid Class II
FDA product code QMA covers "Blood Collection Device For Cell-Free Nucleic Acid", a Class II medical device regulated under 21 CFR 862.1676. Submissions are reviewed by the Clinical Chemistry panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QMA
- Device Class
- Class II
- Regulation Number
- 862.1676
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
A blood collection device for cell-free nucleic acids is a device intended for medical purposes to collect, store, transport, and handle blood specimens and to stabilize and isolate cell-free nucleic acid components prior to further testing.