GJC · Assay, Sulfhemoglobin
Hematology · 21 CFR 864.7490 · Class 2
Overview
| Product Code | GJC |
|---|---|
| Device Name | Assay, Sulfhemoglobin |
| Regulation | 21 CFR 864.7490 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A sulfhemoglobin assay is a device consisting of the reagents, calibrators, controls, and instrumentation used to determine the sulfhemoglobin (a compound of sulfur and hemoglobin) content of human blood as an aid in the diagnosis of sulfhemoglobinemia (presence of sulfhemoglobin in the blood due to drug administration or exposure to a poison). This measurement may be made using methods such as spectroscopy, colorimetry, spectrophotometry, or gasometry.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
