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e-CFR data is current as of September 18, 2020

Title 21Chapter ISubchapter HPart 864Subpart 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]

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