Regulatory Text
21 C.F.R. § 862.1040 — Aldolase test system.
§ 862.1040 Aldolase test system. (a) Identification. An aldolase test system is a device intended to measure the activity of the enzyme aldolase in serum or plasma. Aldolase measurements are used in the diagnosis and treatment of the early stages of acute hepatitis and for certain muscle diseases such as progressive Duchenne-type muscular dystrophy. (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
Official Source ↗
Root-LD Entity Data
◈ Machine-Readable Provenance Record
Root-LD v1.0 · boisestandard.org
Federation ID
BS-CFR21-SEC-CD8E5B
Entity Class
REGULATION / FEDERAL-CFR-SECTION
Domain Signature
boisestandard.org
Citation
21 C.F.R. § 862.1040
Corpus
CFR — Code of Federal Regulations
Status
✓ ACTIVE
Source
PRIMARY-SOURCE
Source Verified
✓ TRUE
Content Hash
3013ebb6b1439b9d...
Semantic Edges
Pending — corpus passes queued
The regulatory text of 21 C.F.R. § 862.1040 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.
Navigate Corpus — Title 21 C.F.R.
Title 21 — Food and Drugs
21 C.F.R. § 1.121 C.F.R. § 1.321 C.F.R. § 1.421 C.F.R. § 1.2021 C.F.R. § 1.2121 C.F.R. § 1.2321 C.F.R. § 1.2421 C.F.R. § 1.7021 C.F.R. § 1.7121 C.F.R. § 1.7221 C.F.R. § 1.7321 C.F.R. § 1.7421 C.F.R. § 1.7521 C.F.R. § 1.7621 C.F.R. § 1.7721 C.F.R. § 1.7821 C.F.R. § 1.7921 C.F.R. § 1.8021 C.F.R. § 1.8121 C.F.R. § 1.8321 C.F.R. § 1.9021 C.F.R. § 1.9121 C.F.R. § 1.9421 C.F.R. § 1.9521 C.F.R. § 1.9621 C.F.R. § 1.9721 C.F.R. § 1.9921 C.F.R. § 1.10121 C.F.R. § 1.22521 C.F.R. § 1.226
21 C.F.R. — public domain
← All Legislation