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Capillary Blood Collection Device For Alternative Site Collection

FDA product code PRJ · 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
2017-02-16 – 2019-11-05

A capillary blood collection device with or without integrated micro-needles is a blood collection device intended to collect and/or transport capillary whole blood specimens for testing of clinical analytes.

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