JLI · Tetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid
Clinical Chemistry · 21 CFR 862.1305 · Class 1
Overview
| Product Code | JLI |
|---|---|
| Device Name | Tetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid |
| Regulation | 21 CFR 862.1305 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A formiminoglutamic acid (FIGLU) test system is a device intended to measure formiminolutamic acid in urine. FIGLU measurements obtained by this device are used in the diagnosis of anemias, such as pernicious anemia and congenital hemolytic anemia.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
