Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma
The Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma is a laboratory instrument used to create pools of whole blood, whole blood lysates, serum, and/or plasma for use in blood donor screening tests, and may include sample preparation steps such as lysing of whole blood samples. It is classified as FDA Class 1, the lowest risk category subject to general controls only, with no requirement for a premarket notification. The product code is QBZ under regulation 862.2750 in the Clinical Chemistry specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QBZ
- Device Class
- FDA class 1
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.