U.S. FDA Medical Device Hematocrit Centrifuge Requirements
FDA Medical Device Definition: A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally high total red cell mass). The packed red cell volume is produced by centrifuging a given volume of blood.
FDA Hematocrit Centrifuge Establishment Registration
FDA Hematocrit Centrifuge Listing
FDA Hematocrit Centrifuge Label Requirements and Exceptions
FDA Hematocrit Centrifuge Import Information
FDA Hematocrit Centrifuge Detentions (Hematocrit Centrifuge Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Hematocrit Centrifuge Manufacturers (Hematocrit Centrifuge Suppliers)
- Hematocrit Centrifuge Distributors
- Hematocrit Centrifuge Processors
- Hematocrit Centrifuge Repackers
- Hematocrit Centrifuge Relabelers
- Hematocrit Centrifuge Exporters
- Hematocrit Centrifuge Importers
For more information about Hematocrit Centrifuge Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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