QBZ — Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma Class I
FDA product code QBZ covers "Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma", a Class I medical device regulated under 21 CFR 862.2750. Submissions are reviewed by the Clinical Chemistry panel.
Classification Details
- Product Code
- QBZ
- Device Class
- Class I
- Regulation Number
- 862.2750
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.