Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 42 - Public Health |
Chapter IV - Centers for Medicare & Medicaid Services, Department of Health and Human Services |
SubChapter G - Standards and Certification |
Part 493 - Laboratory Requirements |
Subpart K - Quality System for Nonwaived Testing |
Analytic Systems |
§ 493.1265 - Standard: Virology.
Latest version.
-
§ 493.1265 Standard: Virology.
(a) When using cell culture to isolate or identify viruses, the laboratory must simultaneously incubate a cell substrate control or uninoculated cells as a negative control material.
(b) The laboratory must document all control procedures performed, as specified in this section.