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Title 21 → Chapter I → Subchapter H → Part 864 → Subpart H → §864.7470 |
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart H—Hematology Kits and Packages
§864.7470 Glycosylated hemoglobin assay.
(a) Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a, A1b, and A1c) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.
(b) Classification. Class II (performance standards).
[45 FR 60621, Sept. 12, 1980]