Blood Collection Device For Cell-Free Nucleic Acid
The Blood Collection Device for Cell-Free Nucleic Acid is a medical device intended to collect, store, transport, and handle blood specimens while stabilizing and isolating cell-free nucleic acid components for subsequent testing, such as liquid biopsy assays. It is used in clinical laboratories to ensure the integrity of cell-free DNA or RNA prior to molecular analysis. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 862.1676 in the Clinical Chemistry specialty. It carries product code QMA and is not an implant, not life-sustaining, and not GMP exempt.
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Basic Information
- Product Code
- QMA
- Device Class
- FDA class 2
- Regulation Number
- 862.1676
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.