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U.S. Department of Health and Human Services

Product Classification

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Device newborn screening specimen collection paper
Regulation Description Blood specimen collection device.
Definition Newborn screening specimen collection paper is a blood collection device intended to be used as medium to collect and transport whole blood specimens from newborns to the laboratory for in vitro diagnostic analysis.
Physical State Newborn screening specimen collection paper is an in vitro diagnostic device that consists of specifically designed filter paper with a uniform surface for the collection of blood spots. The collection paper is in the format of a printed card that incorporates a section for the collection of the patient¿s demographic information.
Technical Method The blood is applied to the indicated spots on the paper. The specimen is allowed to dry and then sent to a laboratory for in vitro diagnostic analysis.
Target Area An in vitro diagnostic device used as a medium to collect and transport whole blood specimen spots to a laboratory
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePJC
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1675
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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