42 C.F.R. § 493.1265   Standard: Virology.


Title 42 - Public Health


Title 42: Public Health
PART 493—LABORATORY REQUIREMENTS
Subpart K—Quality System for Nonwaived Testing
Analytic Systems

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§ 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.

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