21 CFR 864.5600 - Automated hematocrit instrument.

Code of Federal Regulations - Title 21: Food and Drugs (2011)

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Title 21: Food and Drugs

CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H: MEDICAL DEVICES

PART 864: HEMATOLOGY AND PATHOLOGY DEVICES

Subpart F: Automated and Semi-Automated Hematology Devices

864.5600 - Automated hematocrit instrument.

(a) Identification. An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

(b) Classification. Class II (performance standards).

[45 FR 60600, Sept. 12, 1980]


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