FDA product code QBZ: Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma
QBZ is the FDA product code for automated platform consisting of software and instrumentation for pooling and/or lysing donor blood, serum, or plasma. It is a Class I device, regulated under 21 CFR 862.2750 and reviewed by the Clinical Chemistry panel. Devices under QBZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma |
| Device class | Class I |
| Regulation | 21 CFR 862.2750 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for QBZ devices
openFDA lists no recalls for product code QBZ.
Frequently asked questions
What is FDA product code QBZ?
QBZ is the FDA product code for automated platform consisting of software and instrumentation for pooling and/or lysing donor blood, serum, or plasma. It is a Class I device, regulated under 21 CFR 862.2750 and reviewed by the Clinical Chemistry panel.
What device class is QBZ?
Class I, regulation 21 CFR 862.2750. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QBZ
- Run a recall and safety report across every QBZ manufacturer
- Watch product code QBZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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