NGB · Test, Glycosylated Hemoglobin, Over The Counter
Hematology · 21 CFR 864.7470 · Class 2
Overview
| Product Code | NGB |
|---|---|
| Device Name | Test, Glycosylated Hemoglobin, Over The Counter |
| Regulation | 21 CFR 864.7470 |
| Device Class | Class 2 |
| Review Panel | Hematology |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
