21 CFR 866.5760
§ 866.5760 Tryptase test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 866.5760, § 866.5760 Tryptase test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89666
- Permanent ID
ys:prov:89666@1- SHA-256
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Full text
(a) Identification. A tryptase test system is a device that aids in the diagnosis of systemic mastocytosis. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings.
(b) Classification. Class II (special controls). The special control is FDA's guideline entitled “Class II Special Controls Guideline: Tryptase Test System as an Aid in the Diagnosis of Systemic Mastocytosis.” For availability of the document, see § 866.1(e).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.