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Newborn Screening Specimen Collection Paper

FDA product code PJC · 2 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.1675
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1996-04-17 – 2013-03-12

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.

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