Regulatory Text
21 C.F.R. § 862.1135 — C-peptides of proinsulin test system.
§ 862.1135 C-peptides of proinsulin test system. (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. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]
Source: ecfr.gov · govinfo.gov — public domain
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BS-CFR21-SEC-1D3738
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Citation
21 C.F.R. § 862.1135
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CFR — Code of Federal Regulations
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The regulatory text of 21 C.F.R. § 862.1135 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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Title 21 — Food and Drugs
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