21 CFR 862.1305
§ 862.1305 Formiminoglutamic acid (FIGLU) test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1305, § 862.1305 Formiminoglutamic acid (FIGLU) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89101
- Permanent ID
ys:prov:89101@1- SHA-256
294333d11bdb45bc5fee80c145d72f858ed2e45d2746f1fc8ab56243680961e4
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Full text
(a) 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.
(b) Classification. 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.