QBZ

Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma

Product code: QBZ
Device name: Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma
Device class: Class 1
21 CFR: 21 CFR 862.2750
Medical specialty: Clinical Chemistry
Marketing pathway: 510(K) Exempt

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QBZ

Classification and pathway per current FDA publications. Data from openFDA (CC0).