QMA
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Blood Collection Device For Cell-Free Nucleic Acid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1676
- Medical specialty
- Clinical Chemistry
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Cell-Free DNA BCT (K231776) | Streck, Inc. | 2024-07-26 |
| Cell-Free DNA BCT (DEN200001) | Streck, Inc. | 2020-08-07 |
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