Capillary Blood Collection Device For Alternative Site Collection
Medical specialty
Clinical Chemistry
Device class
2
Regulation number
862.1675
Review panel
CH
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
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.