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U.S. Department of Health and Human Services

Product Classification

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Device blood collection device for cell-free nucleic acid
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.
Physical State Direct-draw blood collection tube.
Technical Method Provides physical containment of blood specimen; integrity of blood specimen is stabilized by chemical reagents.
Target Area Human blood
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeQMA
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1676
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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