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Blood/Plasma Collection Device For Dna Testing

FDA product code PJE · 7 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
1998-02-24 – 2023-06-21

A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.

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