21 CFR 862.1450
§ 862.1450 Lactic acid test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1450, § 862.1450 Lactic acid test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89133
- Permanent ID
ys:prov:89133@1- SHA-256
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Full text
(a) Identification. A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
(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 § 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.