21 CFR 862.1100
§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1100, § 862.1100 Aspartate amino transferase (AST/SGOT) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89055
- Permanent ID
ys:prov:89055@1- SHA-256
1421a18624dc66f0b38b19ae087cce890f668caaa02b758155561b25ea48e7ee
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Full text
(a) Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
(b) Classification. Class II (special 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.