QMA — Blood Collection Device For Cell-Free Nucleic Acid Class II
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.