21 CFR 866.2050
§ 866.2050 Staphylococcal typing bacteriophage.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 866.2050, § 866.2050 Staphylococcal typing bacteriophage, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89446
- Permanent ID
ys:prov:89446@1- SHA-256
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Full text
(a) Identification. A staphylococcal typing bacteriophage is a device consisting of a bacterial virus intended for medical purposes to identify pathogenic staphylococcal bacteria through use of the bacteria's susceptibility to destruction by the virus. Test results are used principally for the collection of epidemiological information.
(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 the limitations in § 866.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.