Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma
QBZ · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.2750
Classification
FDA Product Code
QBZ
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 862.2750
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.