21 C.F.R. · Food and Drugs
21 C.F.R. § 864.9600

Potentiating media for in vitro diagnostic use.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 864.9600 — Potentiating media for in vitro diagnostic use.

§ 864.9600 Potentiating media for in vitro diagnostic use. (a) Identification. Potentiating media for in vitro diagnostic use are media, such as bovine albumin, that are used to suspend red cells and to enhance cell reactions for antigen-antibody testing. (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 § 864.9. [45 FR 60649, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]

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-9D4EF0
Entity Class
REGULATION / FEDERAL-CFR-SECTION
Domain Signature
boisestandard.org
Citation
21 C.F.R. § 864.9600
Corpus
CFR — Code of Federal Regulations
Status
✓ ACTIVE
Source
PRIMARY-SOURCE
Source Verified
✓ TRUE
Content Hash
924d2cdec203ec14...
Semantic Edges
Pending — corpus passes queued
The regulatory text of 21 C.F.R. § 864.9600 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.
◈ Provenance
boisestandard.org United States Law CFR Title 21 21 C.F.R. § 864.9600