21 CFR 862.1135
§ 862.1135 C-peptides of proinsulin test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1135, § 862.1135 C-peptides of proinsulin test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89063
- Permanent ID
ys:prov:89063@1- SHA-256
b7d2cdf655030270632369b2df6d442ffac585ccde408ab44d4443a01c4fce80
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. A C-peptides of proinsulin test system is a device intended to measure C-peptides of proinsulin levels in serum, plasma, and urine. Measurements of C-peptides of proinsulin are used in the diagnosis and treatment of patients with abnormal insulin secretion, including diabetes mellitus.
(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.