Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma
Medical specialty
Clinical Chemistry
Device class
1
Regulation number
862.2750
Review panel
CH
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
Instrument used to create pools of whole blood, whole blood lysates, serum, and /or plasma, for use in blood donor screening tests. May include sample preparation steps such as lysing of whole blood samples.